BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 2142149 · Received June 28, 2011

    Report

    Report Number
    2243471-2011-00063
    Date Received
    June 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MKT
    PMA / PMN Number
    BL125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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): RESULT - DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION - NO FAILURE DETECTED AND PRODUCT IS WITHIN SPECIFICATION. THE CUSTOMER REPORTED THAT THEY OBTAINED A NON-REACTIVE RESULT FROM A DONOR WITH THE COBAS TAQSCREEN MPX TEST BUT THE DONOR SPECIMEN WAS SEROLOGY (B)(4). TWO COLLECTIONS FROM THE SAME DONOR WERE TESTED AND BOTH GENERATED NON-REACTIVE MPX RESULTS. THE SECOND COLLECTION WAS ALSO TESTED BY THE CUSTOMER WITH THE COBAS AMPLIPREP / COBAS (CAP/CTM) TAQMAN HBV TEST AND GENERATED A RESULT OF TARGET NOT DETECTED (TND), INDICATING THAT THE SAMPLE LIKELY HAS A TITER BELOW THE LIMIT OF DETECTION (LOD) OF 12 IU/ML OF THE CAP/CTM HBV TEST. NO SAMPLES WERE AVAILABLE FROM THE CUSTOMER FOR FURTHER EVALUATION THE DONATION WAS BLOCKED FROM THE BLOOD SUPPLY. BASED ON THE INFORMATION AVAILABLE, NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(4) REPORTED THAT A PATIENT SAMPLE GENERATED A FALSE (B)(6) TEST RESULT, FOR HBV, WHEN TESTED WITH THE COBAS TAQSCREEN MPX TEST. SPECIFICALLY, THE CUSTOMER REPORTED THAT THE DONOR SPECIMEN WAS SEROLOGY (B)(6) AND GENERATED (B)(6) TEST RESULTS WITH THE COBAS TAQSCREEN MPX TEST. THE PATIENT SAMPLE WAS TESTED FOR SEROLOGY MULTIPLE TIMES WITH THE ARCHITECT (ABBOTT) AND MUREX (DIASORIN) TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST HEPATITIS VIRAL B DNA DETECTION MKT ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1