BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6792674 · Received August 14, 2017

    Report

    Report Number
    2243471-2017-00022
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 9, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC
    Product Code
    MZF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6), ALLEGED THAT RESULT DISCREPANCIES WERE GENERATED FOR A DONOR SAMPLE WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM BASED ON SEROLOGY AND/OR RETEST RESULTS WITH THE COBAS® TAQSCREEN MPX TEST, V2.0. THE SAMPLE WAS FROM A BLOOD DONOR AND THE DISCREPANCIES WERE OBSERVED DURING ROUTINE SCREENING. THE DONOR IS SUSPECTED TO BE HIV-2 POSITIVE, BASED ON POSITIVE SEROLOGY RESULTS INCLUDING THE NON-ROCHE HIV TRIDOT RAPID CARD TEST USED FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES. SAMPLE FROM THIS DONOR WAS TESTED 3 TIMES WITH THE COBAS TAQSCREEN MPX V2.0 TEST, CE-IVD. FROM THE TESTING, HIV WAS INCONSISTENTLY DETECTED, WITH 2 NON-REACTIVE HIV RESULTS BEING GENERATED WITH COMPLAINT KIT LOTS 219650 AND 230804 (TEST DATES: (B)(6) 2017 AND 19(B)(6) 2017) AND ONE HIV REACTIVE RESULT WAS GENERATED WITH A LATE HIV TARGET CT VALUE, WHICH IS INDICATIVE THAT THIS DONOR SAMPLE IS BELOW THE LIMIT OF DETECTION FOR HIV-2. CONCENTRATIONS BELOW THE LIMIT OF DETECTION ARE NOT EXPECTED TO BE CONSISTENTLY DETECTED. THE DONOR SAMPLE WAS RETURNED FOR FURTHER INVESTIGATION, WHICH INCLUDED TESTING WITH THE COMPLAINT COBAS TAQSCREEN MPX TEST V2.0, THE ABBOTT REALTIME HIV-1 ASSAY, THE ROCHE COBAS MPX TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS, THE ROCHE COBAS HIV-1 TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS, AND SEQUENCE ANALYSIS. THE FOLLOWING RESULTS WERE GENERATED: COBAS TAQSCREEN MPX TEST, V2.0: 2 REPLICATES WERE TESTED AND GENERATED NON-REACTIVE RESULTS FOR HIV. ABBOTT REALTIME HIV-1 ASSAY: 2 REPLICATES OF THE DONOR SAMPLE TESTED AND GENERATED "NOT DETECTED" RESULTS FOR HIV-1. THESE RESULTS INDICATE THAT THE DONOR SAMPLE DOES NOT CONTAIN DETECTABLE HIV-1. COBAS MPX FOR USE ON THE COBAS 6800/8800 SYSTEMS: 2 REPLICATES OF THE DONOR SAMPLE WERE TESTED. ONE REPLICATE GENERATED A REACTIVE HIV RESULT, WHILE THE OTHER REPLICATE GENERATED A NON-REACTIVE HIV RESULT. THE RESULTS INDICATED THAT THE DONOR SAMPLE CONTAINED INTERMITTENTLY DETECTABLE HIV WITH THIS TEST AS IT CONTAINS A CONCENTRATION OF HIV BELOW THE TEST'S LOD, BASED ON THE CT VALUE GENERATED. COBAS HIV-1 TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS: 2 REPLICATES OF THE DONOR SAMPLE WERE TESTED AND GENERATED "TARGET NOT DETECTED" RESULTS. THESE RESULTS INDICATE THAT THE DONOR SAMPLE DOES NOT CONTAIN DETECTABLE HIV-1. NO IDENTIFIABLE HIV SEQUENCE WAS OBTAINED FROM MULTIPLE ATTEMPTS TO AMPLIFY, GEL EXTRACT AND SEQUENCE THIS DONOR SAMPLE. THE TOTALITY OF RESULTS FOR THIS DONOR SAMPLE SUGGEST THAT THIS SAMPLE HAS A LOW CONCENTRATION OF HIV-2 THAT IS BELOW THE LIMIT OF DETECTION OF THE COMPLAINT COBAS TAQSCREEN MPX TEST, V2.0, AND AS SUCH, THE OBSERVED VARIABILITY BETWEEN HIV REACTIVE RESULTS AND HIV NON-REACTIVE RESULTS GENERATED WITH THIS PRODUCT CAN BE EXPECTED. ADDITIONALLY, THE COMPLAINT KIT LOTS USED AT THE SITE TO TEST THE DONOR (LOTS 219650 AND 230804) WERE TESTED AND RESULTS MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY ON-GOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW UP REPORT. (B)(4). (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6), (B)(6) BLOOD CENTRE, ALLEGED THAT RESULT DISCREPANCIES WERE GENERATED FOR 2 DONOR SAMPLES WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM BASED ON SEROLOGY AND/OR RETEST RESULTS WITH THE COBAS® TAQSCREEN MPX TEST. THE SAMPLES WERE FROM BLOOD DONORS AND THE DISCREPANCIES WERE OBSERVED DURING ROUTINE SCREENING. DONOR #1 IS SUSPECTED TO BE (B)(6), BASED ON (B)(6) SEROLOGY RESULTS INCLUDING THE NON-ROCHE (B)(4) TRIDOT RAPID CARD TEST USED FOR THE DETECTION OF (B)(6) ANTIBODIES. SAMPLE FROM THIS DONOR WAS TESTED 3 TIMES WITH THE COBAS TAQSCREEN MPX V2.0 TEST, CE-IVD. FROM THE TESTING, (B)(6) WAS INCONSISTENTLY DETECTED, WITH 2 (B)(6) RESULTS BEING GENERATED WITH COMPLAINT KIT LOTS 219650 AND 230804 (TEST DATES: (B)(6) 2017) AND ONE (B)(6) RESULT WAS GENERATED WITH (B)(6) WITH KIT LOT 230804 (TEST DATE: (B)(6)2017). THIS MDR ADDRESSES DONOR #1. A SEPARATE MDR WILL BE FILED TO ADDRESS THE OTHER DONOR ALLEGED (DONOR #2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571582 NA NA MZF ROCHE MOLECULAR SYSTEMS, INC NA 219650

    Patients

    Seq Age Sex Outcome Treatment
    1