BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEAVA LCG BASIC II

    MDR report key: 1022294 · Received March 28, 2008

    Report

    Report Number
    MW5006095
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INVERNESS MEDICAL PROFESSIONAL DI
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS PREGNANCY TEST STRIPS - GIVING FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEAVA LCG BASIC II NONE LCX INVERNESS MEDICAL PROFESSIONAL DI HCG7060200

    Patients

    Seq Age Sex Outcome Treatment
    1