BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD

    MDR report key: 1917263 · Received December 8, 2010

    Report

    Report Number
    2243471-2010-00045
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MKT
    PMA / PMN Number
    P050028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS UNDER INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) -PERFORMANCE TESTS PERFORMED. (B)(4) - CONFIGURATION ISSUE. (B)(4) - DEVICE INCORRECTLY PREPARED FOR USE OR MODIFIED. ADDITIONAL INFORMATION; DEVICE EVALUATION. URGENT MEDICAL DEVICE CORRECTION ADDITIONAL INFORMATION PROVIDED. ROCHE MOLECULAR DIAGNOSTICS HAS CONFIRMED AN ISSUE REGARDING LIQUID LEVEL DETECTION OF THE CS1 MAGNETIC GLASS PARTICLES (MGP) REAGENT CASSETTE OF THE COBAS AMPLIPREP/COBAS TAQMAN (CAP/CTM) HBV V2.0 TEST ON THE COBAS AMPLIPREP INSTRUMENT. THE TEST DEFINITION FILES (TDF) FOR CAP/CTM HBV V2.0 DO NOT HAVE LEVEL DETECTION ACTIVATED FOR THE CS1 (MGP) REAGENT CASSETTE. IN THE EVENT THAT A CS1 REAGENT CASSETTE IS MISASSEMBLED AND NO MGP REAGENT IS PRESENT, IT WOULD NOT BE DETECTED WHEN USING THE CAP/CTM HBV V2.0 TEST. THE LOAD CHECK WOULD NOT RECOGNIZE THE MISSING REAGENT AND THE RUN WOULD CONTINUE, WITH THE POSSIBILITY OF PRODUCING ERRONEOUS BUT BELIEVABLE RESULTS. THE FOLLOWING ASSAYS ARE AFFECTED: COBAS AMPLIPREP-COBAS TAQMAN HBV V 2.0 US-IVD, M/N (B)(4). COBAS AMPLIPREP - COBAS TAQMAN HBV V 2.0 CE-IVD, M/N (B)(4). THE MISASSEMBLED REAGENT CASSETTE IS BELIEVED TO BE A SINGLE OCCURRENCE, CAUSED BY HUMAN ERROR. (B)(4). THE TEST DEFINITION FILES FOR THE CAP/CTM HBV V2.0 TEST WILL BE UPDATED WITH LIQUID LEVEL DETECTION FOR THE CS1 REAGENT CASSETTE ACTIVATED. THIS CORRECTIVE ACTION WILL PREVENT THE ISSUE FROM RECURRING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) FILED A COMPLAINT ALLEGING THAT THE MGP (MAGNETIC GLASS PARTICLE) REAGENT BOTTLE WAS MISPLACED WITHIN CASSETTE 1 (CS1) OF A KIT CAP-G/CTM HBV V2.0 72TESTS CE-IVD (M/N 04894570190; LOT N05553). UNFLAGGED RESULTS WERE GENERATED WITH THIS CASSETTE AND NO ERROR MESSAGES WERE GENERATED EVEN THOUGH THE COBAS AMPLIPREP INSTRUMENT WAS NOT PIPETTING ANY MGP REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD HEPATITIS VIRAL B DNA DETECTION MKT ROCHE MOLECULAR SYSTEMS N05553

    Patients

    Seq Age Sex Outcome Treatment
    1