KIT COBAS 58/68/8800 MPX 480T US

Additional Manufacturer Narrative

THE REPORTED EVENT OCCURRED ON A COBAS 8800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 58/68/8800 MPX 480T US-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. THERE WAS NO INDICATION OF A HARDWARE ISSUE, ALGORITHM MISCALLING, OR REAGENT LOT ISSUE. ALL POSITIVE CONTROLS WERE VALID, CONFIRMING PROPER SAMPLE PROCESSING, AMPLIFICATION, AND DETECTION. A REVIEW OF THE QUALITY CONTROL DATA FOR BATCH M07839 DID NOT CORROBORATE THE CUSTOMER'S ALLEGATION OF FALSE POSITIVES. THE MOST LIKELY CAUSE FOR SOME OF THE DISCREPANT HBV RESULTS WAS IDENTIFIED AS SAMPLES CONTAINING A VIRAL CONCENTRATION NEAR OR AT THE LIMIT OF DETECTION OF THE ASSAY, WHERE WAVERING RESULTS BETWEEN REACTIVE AND NON-REACTIVE MAY OCCUR. CONTAMINATION, WHILE UNLIKELY, COULD NOT BE ENTIRELY EXCLUDED DUE TO THE STABILITY OF HBV AS A DNA TARGET. NO PREVIOUSLY RELATED INTERNAL INVESTIGATIONS WERE IDENTIFIED, AND THIS WAS THE FIRST CASE REPORTED AGAINST THE ALLEGED LOT FOR A FALSE POSITIVE RESULT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

Description of Event or Problem

THE INITIAL REPORTER ALLEGED AN INCREASE IN FALSE REACTIVE HEPATITIS B VIRUS (HBV) RESULTS WHEN USING THE KIT COBAS 58/68/8800 MPX 480T US-IVD ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVED HISTORIC DONOR SAMPLES WITH NEGATIVE SEROLOGY RESULTS. THE CUSTOMER USES PLASMA SAMPLES THAT ARE COLLECTED, STORED, AND HANDLED ACCORDING TO RECOMMENDED PROCEDURES AND GUIDELINES. SEROLOGY TESTING IS PERFORMED ON THE CUSTOMER'S IN-HOUSE PLATFORM, THE ABBOTT ALINITY. MULTIPLE SAMPLES WERE REPORTED AS HBV REACTIVE ACROSS VARIOUS CONTROL BATCHES. FOR EXAMPLE, SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21862 AND CONTROL BATCH 21196. SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21176 AND CONTROL BATCH 21196. SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21382 AND CONTROL BATCH 21932. SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21924 AND CONTROL BATCH 21932. SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21376 AND CONTROL BATCH 21932. SAMPLE ID (B)(6) WAS HBV REACTIVE ON CONTROL BATCH 21376 AND CONTROL BATCH 21932. ADDITIONAL SAMPLES WERE ALSO REPORTED AS HBV REACTIVE ACROSS VARIOUS CONTROL BATCHES. THE CUSTOMER WAS UNCERTAIN WHETHER THE ALLEGED FALSE REACTIVE HBV RESULTS LED TO THE REJECTION OF TISSUE OR ORGAN DONATIONS.