Alere Afinion ™ as100 Analyzer us


Patient and control results records



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Patient and control results records 

The patient and control results are stored in the memory of the Alere Afinion™ AS100 Analyzer. The last 500 patient results and the 

last 500 control results are saved in separate records. When exceeding the capacity of 500 results, the oldest result will be deleted. 

The following parameters are listed for each run: Date and time, run number, patient ID/control ID, operator ID, lot number of Test 

Cartridge and the test result.

View, print and export patient and control results

1

Main menu 

Touch 

 to enter patient results.



Touch 

 to enter control results.



2

The last patient result or control is displayed. 

To view more results touch 

 or 


 

If a printer is connected, touch 

 to print the result.

Result records may be exported if a USB flash (FAT 32 formatted) is inserted into the Alere Afinion™ USB port.   

Touch 

to export the results. The results will be stored on the USB in a .txt file for each assay tested on the Alere Afinion™ 



AS100 Analyzer. These files may be opened in e.g. Microsoft Excel for further processing.

Caution

When you export data that contains patient information, it is your responsibility to comply with your local regulations on 

protection of personal health information.

TESTING PROCEDURES



  27

When an information code appears

Information codes that might appear during use of the Alere Afinion™ AS100 Analyzer refer to specific information messages.  

The code numbers, the possible causes and actions to take are listed below. 

If the Analyzer detects a problem during processing of a Test Cartridge, the test will automatically be aborted and the Test Cartridge 

will be safely moved to the cartridge chamber. Proceed as follows:

1

Record the code number (#) and touch 

 to accept.

The lid opens automatically.



2

Remove the Test Cartridge.

If the Test Cartridge is not ejected, restart the Analyzer.

Do not re-use the Test Cartridge.



3

Look up the possible cause from the table below, and take actions to solve the problem.

If the problem persists, contact your local Alere Afinion™ supplier (see “Service information” page 29).

Do not re-use a Test Cartridge that has been rejected by the Analyzer. Collect a new sample and repeat the test  

with a new Test Cartridge. 

Information codes caused by assay specific limitations

[#]  


Cause

Action to take

103

Hemoglobin too low



Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.

104


Hemoglobin too high

Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.

105

HbA1c too low



Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.

106


HbA1c too high

Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.

107

Creatine too high



Consult the Alere Afinion™ ACR Package Insert.

108


Blood in urine

Consult the Alere Afinion™ ACR Package Insert.



INFORMATION CODES AND TROUBLESHOOTING


28  

INFORMATION CODES AND TROUBLESHOOTING

Information codes caused by sample or Test Cartridge failure

[#]


Cause

Action to take

201

Insufficient sample volume:



- Empty capillary

- Air bubble in capillary

- Capillary incompletely filled

Repeat the test with a new sample and Test Cartridge. 

Ensure that the capillary is completely filled with no air bubbles.

202


Excess sample on the sampling 

device exterior

Repeat the test with a new sample and Test Cartridge. 

Ensure that only the tip of the capillary is in contact with the sample. 

203

Wrong sample material



Repeat the test with a new sample and Test Cartridge. Ensure that proper sample  

material is used (see Package Insert for the Alere Afinion™ test in use, section  

Specimen collection and storage).

204


Coagulated sample

Repeat the test with a new sample and Test Cartridge. 

The time from filling the capillary until analyzing the Test  

Cartridge should be as short as possible.

Hemolysed blood sample  

(Alere Afinion™ HbA1c)

Consult the Alere Afinion™ HbA1c Package Insert. 

Repeat the test with a new sample and Test Cartridge.

Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge. 

If the problem persists, restart the Analyzer and run controls.

205

Capillary cracked or damaged



Repeat the test with a new sample and Test Cartridge. 

Inspect the sampling device before use and handle with care.

206

Barcode label not readable  



(dirty or damaged)

Repeat the test with a new sample and Test Cartridge. 

If the problem persists, restart the Analyzer and run controls.

207


No sampling device inserted

Repeat the test with a new sample and Test Cartridge.

Used sampling device belongs 

to another Alere Afinion™ test

Repeat the test with a new sample and Test Cartridge. Ensure that the sampling device 

and Test Cartridge have the same label color.

Label on sampling device not 

readable (dirty or damaged)

Repeat the test with a new sample and Test Cartridge. Ensure that the label is clean.

208


Test Cartridge previously used

Repeat the test with a new sample and Test Cartridge.

209

Test Cartridge has passed 



expiration date

Check expiration date on the Cartridge pouch or box. 

Repeat the test using a new sample and a new Test Cartridge from another lot.

The date in the Analyzer is  

incorrectly set

Check the date in the Analyzer to make sure it is set correctly.  

Repeat the test with a new sample and Test Cartridge.

210


Test Cartridge temperature too 

low


Repeat the test with a new sample and a new Test Cartridge within recommended 

operating temperature range (see Package Insert for the Alere Afinion™ test in use).

211

Test Cartridge temperature too 



high

Repeat the test with a new sample and a new Test Cartridge within recommended 

operating temperature range (see Package Insert for the Alere Afinion™ test in use, 

section Test procedure).

212

Test Cartridge not recognized  



by the Analyzer

The software version required for this test is not installed. 

Contact your local supplier for assistance.

213


214

215


Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge.  

If the problem persists, restart the Analyzer and run controls.

217

Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge.  



If the problem persists, restart the Analyzer and run controls.

218


Condensation detected on 

cartridge

Run a new test cartridge, ensure that the cartridge is equilibrated to room temperature 

before the foil pouch is opened.



Information codes or messages caused by Analyzer failure

[#]


Cause

Action to take

301

Self-test failed



Restart the Analyzer.

302


Analyzer failure

Restart the Analyzer and run controls.  

Repeat the test with a new sample and Test Cartridge.

303


Analyzer temperature is too high Ensure that the operating temperature is within recommended range (15-32°C, 59-89°F). 

Wait until the Analyzer has cooled down. Repeat the test with a new sample and Test 

Cartridge.

304


Analyzer temperature is too low

Ensure that the operating temperature is within recommended range for the Alere 

Afinion™ test in use (see Package Insert). The Analyzer temperature is displayed in the 

Start-Up menu (see page 13). Repeat the test with a new sample and Test Cartridge.

305

- Printer improperly connected



- Malfunction of the printer

Power off the Analyzer, reconnect the printer and restart the Analyzer.  

If the message persists, see the printer User Manual.





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