BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQMAN HBV ANALYTE SPECIFIC REAGENT SET

    MDR report key: 601410 · Received February 11, 2005

    Report

    Report Number
    2243471-2005-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2005
    Report Date
    January 14, 2005
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    LOM
    Removal / Correction Number
    2243471-02-11-05-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN JANUARY 2005, ROCHE MOLECULAR SYSTEMS, INC. FOUND THROUGH INTERNAL INVESTIGATION THAT BHV QS, LOT F10513, CONTAINS A LOW LEVEL OF RECOMBINANT HIV DNA THAT WAS INADVERTENTLY INTRODUCED DURING THE FILLING PROCESS. BHV QS LOT F 10513 WAS MANUFACTURER ON OCTOBER 4, 2004 AND WAS PACKAGED INTO THE TAQMAN, TAQMAN HBV ANALYTE SPECIFIC REAGENT, M/N 3322092018, LOT F10185 (EXP DATE: 9/30/2005) ON DECEMBER 13, 2004 THE TAQMAN HBV ANALYTE SPECIFIC REAGENT IS USED BY CUSTOMERS IN "HOME-BREW" PCR ASSAYS FOR THE DETECTION AND/OR QUANTITATION OF HBV DNA. BECAUSE OF THE SPECIFICITY OF THE PCR AMPLIFICATION AND DETECTION PROCESS, THE HIV DNA CAN ONLY BE DETECTED IF THE HBV QS IS AMPLIFIED AND DETECTED USING HIV PRIMERS AND PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAQMAN HBV ANALYTE SPECIFIC REAGENT SET HBV ASR LOM ROCHE MOLECULAR SYSTEMS, INC. NA F10185

    Patients

    Seq Age Sex Outcome Treatment
    1 *