BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON HCG DIPSTICK (25T)

    MDR report key: 3928491 · Received June 6, 2014

    Report

    Report Number
    2027969-2014-00555
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING UNCONFIRMED FALSE NEGATIVE HCG USING MCKESSON PREGNANCY KIT. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331722 MCKESSON HCG DIPSTICK (25T) HCG PREGNANCY TEST DKZ ALERE SAN DIEGO, INC. FHC-111-OBN01 HCG3080017

    Patients

    Seq Age Sex Outcome Treatment
    1