COBAS B 101 HBA1C TEST

Additional Manufacturer Narrative

THE DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE HEMOGLOBIN A1C RESULTS FOR 2 PATIENTS FROM A COBAS B 101 ANALYZER WHEN COMPARED TO THE BIO-RAD D-100 CHROMATOGRAPH IN ANOTHER LABORATORY. THE B 101 SERIAL NUMBER WAS (B)(4). FOR PATIENT 1 THE A1C RESULT FROM THE B 101 WAS 5.7%. FOR PATIENT 1 THE A1C RESULT FROM THE BIO-RAD D-100 WAS 4.8%. PATIENT 1 YEAR OF BIRTH WAS PROVIDED AS (B)(6). FOR PATIENT 2 THE A1C RESULT FROM THE B 101 WAS 5.6%. FOR PATIENT 2 THE A1C RESULT FROM THE BIO-RAD D-100 WAS 4.8%. PATIENT 2 WAS A (B)(6) MALE WITH A BIRTH YEAR PROVIDED AS (B)(6). THE SAME SAMPLE COLLECTION FOR EACH PATIENT WAS USED ON BOTH INSTRUMENTS AND THE SAMPLES WERE WHOLE BLOOD.

Additional Manufacturer Narrative

THE MANUFACTURER BATCH RECORD FOR COBAS B101 HBA1C OF LOT 915041-01 HAS BEEN CONSULTED AND SHOWED NO ABNORMALITIES. THE MANUFACTURER'S 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: FOURTEEN "LOW" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 A RETENTION COBAS B101 INSTRUMENT. FOURTEEN "MIDDLE" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 A RETENTION COBAS B101 INSTRUMENT. 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. LOW RANGE DEVIATIONS WERE BETWEEN -0.1 ¿ 0.3 % NGSP. THE AVERAGE DEVIATION WAS 0.11% NGSP. MIDDLE RANGE DEVIATIONS WERE BETWEEN 0.1 - 0.4% NGSP. THE AVERAGE DEVIATION WAS 0.27% NGSP. HIGH RANGE DEVIATIONS WERE BETWEEN -0.4 ¿ 0% NGSP. THE AVERAGE DEVIATION WAS -0.16% NGSP. THE RETENTION MATERIAL MEASUREMENTS ON THE RETENTION COBAS B101 INSTRUMENT SHOWED NO HBA1C DEVIATION COMPARED TO TOSOH G8 (MAXIMUM DEVIATION BETWEEN THE RETENTION MATERIAL AND TOSOH G8 WAS 0.27%). (THE CUSTOMER¿S DEVIATION WAS 0.8 ¿ 0.9% NGSP AT LOW RANGE WHEN COMPARED TO THE LAB METHOD BIO-RAD D-100). THE ERROR AND AUDIT TRAIL LOGS THAT THE CUSTOMER PROVIDED WERE ANALYZED AND CONTAINED SEVERAL WARNINGS AND ERRORS WHICH ARE NOT INDICATIVE OF A POTENTIAL RESULT DEVIATION. SEVERAL ENTRIES SHOWED THERE WERE REAGENT DISC HANDLING ERRORS. BASED ON THE ERRORS, THE INSTRUMENT MAY HAVE HAD SOME DAMAGE ON THE BEARING PLATE AND GEAR. TWO COBAS B101 HBA1C LOT 915041-01 REAGENT DISCS WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION. MEASUREMENTS WERE PERFORMED USING THE CUSTOMER MATERIAL AND RETENTION MATERIAL AS FOLLOWS: TWO "LOW" WHOLE BLOOD SAMPLES WERE MEASURED WITH THE RETURNED TEST DISCS OF COBAS B101 HBA1C LOT 915041-01 ON A RETENTION COBAS B101 INSTRUMENT. FIVE "LOW" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 915041-01 ON A RETENTION COBAS B101 INSTRUMENT. THERE WERE NO DISCREPANT HBA1C RESULTS MEASURED WITH THE CUSTOMER MATERIAL AND RETENTION MATERIAL OF HBA1C DISCS OF LOT 915041-01. DISCREPANT HBA1C RESULTS COULD NOT BE CONFIRMED. LOW RANGE DEVIATIONS ON THE CUSTOMER¿S RETURNED DISCS WERE BETWEEN 0.1 ¿ 0.2 % NGSP. LOW RANGE DEVIATIONS WITH RETENTION MATERIAL WERE BETWEEN 0 - 0.1% NGSP. CONCLUSION OF THE CUSTOMER RETURNED MATERIAL MEASUREMENTS AND THE RETENTION MATERIAL MEASUREMENTS: THE CLAIMED, RETURNED MATERIAL WAS MEASURED USING WHOLE BLOOD LOW. THE RESULTS SHOWED THAT 0.1 ¿ 0.2% NGSP DEVIATION WITH TOSOH G8. RETENTION MATERIAL WAS MEASURED AT THE SAME TIME. THE DATA SHOWED THAT THE DEVIATION WAS 0.1 ¿ 0.2 % NGSP. THE CLAIMED ALLEGATION COULD NOT BE VERIFIED.