BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE COBAS AMPLIPREP INSTRUMENT

    MDR report key: 1060978 · Received June 12, 2008

    Report

    Report Number
    2243471-2008-00007
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    March 25, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE INSTRUMENT CENTER
    Product Code
    JQW
    PMA / PMN Number
    K012966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE COBAS AMPLIPREP INSTRUMENT STATION, PEPET&DILUTE, FOR CLINICAL USE JQW ROCHE INSTRUMENT CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1