BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 3201931 · Received July 2, 2013

    Report

    Report Number
    2243471-2013-00018
    Date Received
    July 2, 2013
    Date of Event
    May 15, 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 FOR 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). SPECIFICATION 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, 2243471-2013-00019 ADDRESS THE OTHER FOUR PATIENT SAMPLE RESULTS. THE INITIAL PATIENT DRAW WAS TESTED ON (B)(6) 2013 AND GENERATED AN (B)(6) TARGET NOT DETECTED (TND) RESULT. A SUBSEQUENT BLOOD DRAW TESTED ON (B)(6) 2013 GENERATED AN (B)(6) LOG TITER OF 2.56. THE PHYSICIAN QUESTIONED THIS RESULT. THIS SAMPLE WAS REPEATED ON (B)(6) 2013 AND GENERATED AN (B)(6) RESULT OF <20 IU/ML. ALL CONTROLS WERE VALID AND IN RANGE FOR ALL RUNS TESTED. THE SAMPLE JJ5709 WAS PROVIDED FOR INVESTIGATIVE TESTING AND GENERATED A TARGET NOT DETECTED (TND) RESULT, WHICH IS IN LINE WITH THE RETEST RESULT OF <20 IU/ML OBTAINED BY THE CUSTOMER. RETAIN KIT TESTING MET SPECIFICATIONS. THE CAUSE OF THE HIGH TITER RESULT OF 2.56 LOG 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 HANDLING INTRODUCING CONTAMINATION AFTER DISPENSING FROM THE PRIMARY TUBE. 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)(6). MDRS 2243471-2013-00015, 2243471-2013-00016, 2243471-2013-00017, 2243471-2013-00019 WILL ADDRESS THE OTHER FOUR PATIENT RESULTS. THE INITIAL PATIENT DRAW WAS TESTED ON (B)(6) 2013 AND GENERATED AN HIV-1 TARGET NOT DETECTED (TND) RESULT. A SUBSEQUENT BLOOD DRAW TESTED ON (B)(6) 2013 GENERATED AN (B)(6). THE PHYSICIAN QUESTIONED THIS RESULT. THIS SAMPLE WAS REPEATED ON (B)(6) 2013 AND GENERATED AN (B)(6). THE ONLY PATIENT INFORMATION CURRENTLY KNOWN IS THAT THE PATIENT IS ON LONG TERM (B)(6) MONITORING. THE ASSOCIATED US PRODUCT IS M/N (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302370 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