BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST US-IVD

    MDR report key: 2222070 · Received August 24, 2011

    Report

    Report Number
    2243471-2011-00078
    Date Received
    August 24, 2011
    Date of Event
    June 29, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULT - DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT IS WITHIN SPECIFICATION. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT PROVIDE ANY RAW DATA OR PATIENT SAMPLES TO PERFORM THE INVESTIGATION. THEREFORE, THE ALLEGED UNDER-QUANTITATION USING CAP/CTM HIV-1 COULD NOT BE CONFIRMED. WITH THE LIMITED AVAILABLE INFORMATION, IT COULD NOT BE DETERMINED IF THE ALLEGATION WAS DUE TO MISMATCHES TO THE PRIMERS/PROBE OF THE TEST. NO SAMPLE WAS RETURNED FOR SEQUENCING ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE, NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. THE ISSUE IS LIKELY SAMPLE-SPECIFIC. A COMPLAINT HISTORY ANALYSIS SHOWS THAT NO OTHER SIMILAR COMPLAINTS WERE REGISTERED FOR THE SAME KIT LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE COMPLAINT INVESTIGATION INTO THIS REPORTED ISSUE IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) ALLEGED THAT (B)(6) TEST RESULTS WERE GENERATED FOR ONE PATIENT SAMPLE WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV-1 TEST, V 1, WHEN COMPARED TO BDNA TEST THE CAP/CTM HIV TEST V 1 RESULT WAS (B)(6). THE PHYSICIAN QUESTIONED THE RESULT, (B)(6). THE SITE SENT THE SAMPLE OUT FOR BDNA TESTING AND THE BDNA RESULT WAS (B)(6). IT IS PLANNED TO HAVE THE SAMPLE SENT FOR SEQUENCING ANALYSIS. IT IS UNKNOWN IF ANY PATIENT TREATMENT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST US-IVD TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS P04427

    Patients

    Seq Age Sex Outcome Treatment
    1