BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOLESTECH GDX

    MDR report key: 1301982 · Received January 21, 2009

    Report

    Report Number
    MW5009815
    Event Type
    Injury
    Date Received
    January 21, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 21, 2009
    Manufacturer
    INVERNESS MEDICAL
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPENED NEW BOX OF AIC CASSETTES & RAN CONTROLS. CONTROLS WERE OUT OF RANGE. CONTACTED TECH SUPPORT & THEY SENT US NEW MACHINE, CONTROLS & CASSETTES. THE CONTROL STILL ARE OUT OF RANGE. WE ARE SENDING MACHINES BACK & GOING TO TRY DIFFERENT COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTECH GDX GDX ANALYZER LCP INVERNESS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1