BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2880044 · Received December 19, 2012

    Report

    Report Number
    2243471-2012-00039
    Date Received
    December 19, 2012
    Date of Event
    October 26, 2012
    Report Date
    January 24, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. UNABLE TO CONFIRM COMPLAINT. NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATIONS. THE CUSTOMER COMPLAINT ALLEGED DISCREPANT RESULTS WERE GENERATED FOR ONE SAMPLE WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(6) TEST, V2.0 CE-IVD. SAMPLE (B)(6) GENERATED A RESULT OF 2.440 CP/ML ON (B)(6) 2012. THE SAME SAMPLE WAS RE-TESTED ON (B)(6) 2012 AND GENERATED A RESULT OF TARGET NOT DETECTED (TND). ALTHOUGH REQUESTED, THE SAMPLE IN QUESTION WAS NOT AVAILABLE FOR INVESTIGATIVE TESTING. WITHOUT HAVING THE SAMPLE, THE CAUSE OF THE RESULT DISCREPANCY CANNOT BE DETERMINED. RETAIN TESTING OF THE COMPLAINT KIT LOT MET SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. _______________ (B)(4).

    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).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING DISCREPANT RESULTS WERE GENERATED FOR ONE SAMPLE WITH THE COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, (B)(6). THE SAME SAMPLE WAS RE-TESTED ON (B)(6) 2012 AND GENERATED A RESULT OF TARGET NOT DETECTED (TND) IT IS CURRENTLY UNKNOWN IF ANY PATIENT TREATMENT WAS AFFECTED BY THE DISCREPANT RESULTS. THE SAMPLE HAS BEEN REQUESTED FOR INVESTIGATIVE TESTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS R00004

    Patients

    Seq Age Sex Outcome Treatment
    1