BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 158442 · Received March 17, 1998

    Report

    Report Number
    1451914-1998-00003
    Event Type
    Malfunction
    Date Received
    March 17, 1998
    Report Date
    March 13, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A NEGATIVE RESULT WAS OBTAINED WITH ABBOTT TESTPACK PLUS HCG COMBO OBC ON A SERUM SAMPLE. THE SAMPLE WAS TESTED WITH AXSYM B-HCG AND WAS FOUND TO BE 48 MIU/ML. NO FURTHER INFO WAS AVAILABLE.

    Description of Event or Problem · 2

    A NEGATIVE RESULT WAS OBTAINED WITH ABBOTT TESTPACK PLUS HCG COMBO OBC ON A SERUM SAMPLE. THE SAMPLE WAS TESTED WITH AXSYM B-HCG AND WAS FOUND TO BE 76 MIU/ML. THE TESTPACK RESULT WAS NOT REPORTED. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-COMBO RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 35806M300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 28 YR