BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG

    MDR report key: 381016 · Received February 28, 2002

    Report

    Report Number
    1451914-2002-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2002
    Date of Event
    January 2, 2002
    Report Date
    February 28, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A TESTPACK FALSE NEGATIVE RESULT WAS GENERATED ON A PT (USING A RANDOM URINE SAMPLE) WHO HAD BEEN CONFIRMED AS PREGNANT WITH THE AXSYM HCG ASSAY. THE AXSYM HCG RESULT WAS 12,000 IU/L. REPEAT TESTING WITH THE TESTPACK ALSO GENERATED A FALSE NEGATIVE RESULT. INFO REGARDING IMPACT TO PT MANAGEMENT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 71532M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other