COBAS B 101 HBA1C TEST

Additional Manufacturer Narrative

THE MANUFACTURER BATCH RECORD FOR COBAS B101 HBA1C OF LOT 915041-01 SHOWED NO ABNORMALITIES. THE MANUFACTURER FINAL PRODUCT INSPECTION REPORT FOR COBAS B101 HBA1C TEST DISCS OF LOT 915041-01 SHOWED NO ABNORMALITIES AND ALL FEATURES PASSED. RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 WAS TESTED WITH WHOLE BLOOD MEASUREMENTS AND HELD AGAINST TARGET VALUES OBTAINED FROM A TOSOH G8 INSTRUMENT: A) FOURTEEN "LOW" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 A RETENTION COBAS B101 INSTRUMENT. B) FOURTEEN "MIDDLE" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 A RETENTION COBAS B101 INSTRUMENT. C) FOURTEEN "HIGH" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 A RETENTION COBAS B101 INSTRUMENT. RESULTS: THERE WERE NO DISCREPANT HBA1C RESULTS MEASURED WITH RETENTION MATERIAL HBA1C DISC LOT 915041-01. DISCREPANT HBA1C RESULTS COULD NOT BE CONFIRMED. A) LOW RANGE DEVIATIONS WERE BETWEEN -0.1 ¿ 0.3 % NGSP. THE AVERAGE DEVIATION WAS 0.1% NGSP. B) MIDDLE RANGE DEVIATIONS WERE BETWEEN 0.1 - 0.4% NGSP. THE AVERAGE DEVIATION WAS 0.3% NGSP. C) HIGH RANGE DEVIATIONS WERE BETWEEN -0.4 ¿ 0% NGSP. THE AVERAGE DEVIATION WAS -0.2% NGSP. THERE WAS NO DATA DEVIATION MEASURED WITH RETENTION MATERIAL OF COBAS B 101 HBA1C DISCS OF LOT 835041-01 ON A RETENTION PHC COBAS B101 INSTRUMENT. ALL OBTAINED RESULTS ARE ACCEPTABLE AND MEET SPECIFICATIONS. DISCREPANT HBA1C RESULTS COULD NOT BE CONFIRMED. LOW RANGE DEVIATIONS WAS 0.0 - 0.2% NGSP. THE AVERAGE DEVIATION IS 0.12% NGSP. MIDDLE RANGE DEVIATIONS WAS 0.1 - 0.4% NGSP. THE AVERAGE DEVIATION IS 0.25% NGSP. HIGH RANGE DEVIATIONS WERE BETWEEN -0.4 ¿ 0% NGSP. THE AVERAGE DEVIATION WAS -0.2% NGSP. THE ERROR AND AUDIT TRAIL LOGS THAT THE CUSTOMER PROVIDED WERE ANALYZED AND CONTAINED WARNINGS AND ERRORS WHICH ARE NOT INDICATIVE OF POTENTIAL RESULT DEVIATIONS. THERE WERE SEVERAL ERROR MESSAGES INDICATING THAT THE INSTRUMENT DETECTED AN ERROR RELATED TO THE SAMPLE VOLUME OR CONDITION DURING AN HBA1C MEASUREMENT. THERE WAS A LOG ENTRY MESSAGE WHICH INDICATED THAT THE AMBIENT TEMPERATURE MEASURED BY THE COBAS B 101 INSTRUMENT WAS OUTSIDE OF THE NORMAL OPERATING TEMPERATURE. FURTHER ERRORS WERE OBSERVED INDICATING THERE WERE REAGENT DISC HANDLING ISSUES IN WHICH THE DISC WAS NOT PUT IN THE INSTRUMENT CORRECTLY. THE INSTRUMENT IS 6 YEARS OLD AND DOES NOT CONTAIN THE LATEST FIRMWARE.

Additional Manufacturer Narrative

THE CUSTOMER RAN AN OPTICAL CHECK ON THE INSTRUMENT AND THIS PASSED. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE COBAS B 101 HBA1C TEST ON COBAS B 101 INSTRUMENT SERIAL NUMBER (B)(4). IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED WITH AN HBA1C VALUE OF 6.9 % WHEN TESTED ON THE COBAS B 101 INSTRUMENT. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN METHOD, RESULTING WITH AN HBA1C VALUE OF 6.2 %. THE RESULT OF 6.2 % MATCHED THE PATIENT'S CLINICAL CONDITION.