BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0

    MDR report key: 3090414 · Received May 2, 2013

    Report

    Report Number
    2243471-2013-00008
    Date Received
    May 2, 2013
    Date of Event
    March 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT ALLEGED THAT THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV-1 V2.0 TEST GENERATED A TARGET NOT DETECTED RESULT ON A PATIENT SAMPLE FROM A KNOWN (B)(6) PATIENT. THE PATIENT, A (B)(6) MAN FROM (B)(6), IS (B)(6) GENOTYPE AG AND HAS BEEN TREATED FOR MANY YEARS. HOWEVER, HE HAS HAD NO TREATMENT WITHIN THE PAST 6 MONTHS. THE PATIENT SAMPLE WAS TESTED WITH THE COBAS AMPLICOR HIV-1 MONITOR TEST, VERSION 1.5 AND GENERATED A RESULT OF 4.88 COPIES/ML. THIS RESULT IS IN LINE WITH THE CAP/CTM TESTING WHICH GENERATED A TARGET NOT DETECTED RESULT. THE TITER OF 4.88 COPIES/ML IS BELOW THE LIMIT OF DETECTION OF THE COBAS AMPLICOR HIV-1 ULTRASENSITIVE TEST, V1.5 (50 CP/ML). THE TITER OBTAINED IS ALSO BELOW THE LIMIT OF THE CAP/CTM HIV V2.0 (20 CP/ML). FURTHERMORE, THE SAMPLE WAS SEQUENCED, AND THE FOLLOWING CONCLUSIONS WERE DRAWN: THERE WAS NO (B)(6) SEQUENCE INFORMATION OBTAINED FROM THE SAMPLE. WITHOUT SEQUENCE INFORMATION, IT CANNOT BE DETERMINED IF THERE ARE ANY MISMATCHES IN THE PRIMER AND PROBE BINDING REGIONS FOR THE CAP/CTM HIV V2.0 OR COBAS® AMPLICOR (B)(6) MONITOR, V1.5 TESTS. THE INABILITY TO OBTAIN SEQUENCE INFORMATION DOES NOT ALWAYS INDICATE THE PRESENCE OR ABSENCE OF HIV-1. THIS COULD POSSIBLY BE DUE TO LOW VIRAL TITER IN THE SAMPLE OR A LACK OF SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR PCR AMPLIFICATION AND SEQUENCING. THE MEDICAL ASSESSMENT FOR THIS CASE INDICATES THAT THE RESULTS WERE LOWER THAN EXPECTED AND THE CUSTOMER IS ALLEGING UNDER QUANTITATION, WHICH CANNOT BE DISPROVEN, BUT THERE WAS NO IMPACT TO PATIENT MANAGEMENT, SO THIS CASE HAS HAD NO MEDICAL HARM. DUE TO THE INABILITY TO GENERATE A SEQUENCE, IT CANNOT BE DETERMINED IF THE PATIENT SAMPLE HAS SEQUENCE MISMATCHES IN THE PRIMER AND PROBE BINDING REGIONS OF BOTH ROCHE TESTS - CAP/CTM HIV-1 V2.0 AND COBAS® AMPLICOR HIV-1 MONITOR, V1.5. IT IS ALSO POSSIBLE THAT THE PATIENT IS AN ELITE CONTROLLER, WHICH COULD HAVE CAUSED THE ALLEGED UNDER QUANTITATION, AND THE CURRENT MEDICAL MANAGEMENT OF THESE PATIENTS IS UNCLEAR. RETAIN KIT TESTING MET SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE OR PRODUCT MALFUNCTION WITH EITHER TEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN THE US FILED A COMPLAINT ALLEGING THAT THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(4) TEST GENERATED A TARGET NOT DETECTED RESULT ON A PATIENT SAMPLE FROM A KNOWN (B)(6) PATIENT. THE PATIENT, (B)(6) AND HAS BEEN TREATED FOR MANY YEARS. HOWEVER, HE HAS HAD NO TREATMENT WITHIN THE PAST 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191273 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS R12372

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR