BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 3201936 · Received July 2, 2013

    Report

    Report Number
    2243471-2013-00019
    Date Received
    July 2, 2013
    Date of Event
    May 17, 2013
    Report Date
    August 12, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE FO THIS REPORT 08/12/2013. DATE RECEIVED BY MANUFACTURER 08/12/2013. FOLLOW UP REPORT 1. ADDITIONAL INFORMATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER: YES. (B)(4) THE COMPLAINT ALLEGED THAT FIVE PATIENTS GENERATED DISCREPANT RESULTS WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(6) V2.0 CE-IVD TEST. THIS MDR IS FOR PATIENT LABORATORY NUMBER (B)(6). MDRS 2243471-2013-00015. 2243471-2013-00016, 2243471-2013-00017, 2243471-2013-00018 ADDRESS THE OTHER FOUR PATIENT SAMPLE RESULTS. THE INITIAL PATIENT DRAW WAS TESTED ON (B)(6) 2013 AND GENERATED AN (B)(6). THE SAMPLE ADDRESSED IN THIS REPORT - (B)(6) - WAS NOT PROVIDED FOR INVESTIGATIVE TESTING. RETAIN KIT TESTING MET SPECIFICATIONS. THE CAUSE OF THE HIGH TITER RESULTS OF (B)(6) IS UNKNOWN. THE MEDICAL ASSESSMENT STATES THAT IT IS POSSIBLE THAT PATIENTS HAD INTERCURRENT ACUTE ILLNESS, SUCH AS THE FLU, CAUSING A VIRAL "BLIP". PATIENTS THAT WERE POSSIBLY NON-ADHERENT TO MEDICATIONS COULD CAUSE A RISE IN VIREMIA AND SUBSEQUENTLY TOOK THEIR MEDICATIONS AS DIRECTED, CAUSING THE VIRAL LOAD TO DECREASE. THE ISSUE COULD ALSO POSSIBLY HAVE BEEN CAUSED BY SAMPLE DEGRADATION. HOWEVER, THE ROOT CAUSE OF THE ISSUE CANNOT BE DEFINITIVELY DETERMINED. AS THE RETAIN KIT TESTING MET SPECIFICATIONS, THERE IS NO INDICATION THAT THE ISSUE OF DISCREPANT RESULTS WAS DUE TO A PRODUCT NON-CONFORMANCE OR MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) FILED A COMPLAINT ALLEGING THAT FIVE PATIENTS GENERATED DISCREPANT RESULTS WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV-1 V2.0 CE-IVD TEST. THIS MDR IS FOR PATIENT LABORATORY NUMBER (B)(4). MDRS 2243471-2013-00015. 2243471-2013-00016, 2243471-2013-00017, 2243471-2013-00018 WILL ADDRESS THE OTHER FOUR PATIENT RESULTS. THE INITIAL PATIENT DRAW WAS TESTED ON (B)(6) 2013 AND GENERATED AN HIV -1 LOG TITER OF (B)(6). A SUBSEQUENT BLOOD DRAW TESTED ON (B)(6) 2013 GENERATED AN HIV-1 LOG TITER OF (B)(6). THIS SAMPLE WAS REPEATED ON (B)(6) 2013 AND GENERATED AN HIV-1 TND RESULT. THE ONLY PATIENT INFORMATION CURRENTLY KNOWN IS THAT THE PATIENT IS ON LONG TERM HIV MONITORING. THE ASSOCIATED US PRODUCT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301464 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS R10631

    Patients

    Seq Age Sex Outcome Treatment
    1