BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 168598 · Received May 18, 1998

    Report

    Report Number
    1451914-1998-00007
    Event Type
    Malfunction
    Date Received
    May 18, 1998
    Date of Event
    March 31, 1998
    Report Date
    May 13, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT LISTED AS INCORRECT MFR DATE OF 10/1997 IN SECTION H.4. THE CORRECTED MFR DATE IS 08/1997. CUSTOMER RETURN SAMPLE WAS REQUESTED BUT WAS NOT AVAILABLE. CUSTOMER RETURN REACTION DISCS FROM LOT 32917M300 WERE EVALUATED. THE RETURN REACTION DISCS MET ACCEPTANCE CRITERIA WHEN TESTED WITH IN-HOUSE PANELS. WITHOUT THE RETURNED SAMPLE IT CANNOT BE DETERMINED IF THE COMPLAINT IS SAMPLE RELATED. THE CUSTOMER OBSERVATION WAS NOT REPRODUCED. EVALUATION COMPLETE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A URINE AND SERUM SAMPLE FROM A PT WERE BOTH NEGATIVE WITH TESTPACK HUMAN CHORIONIC GONADOTROPIN COMBO. THE SERUM SAMPLE WAS TESTED ON THE IMX AND WAS 99 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-COMBO RAPID PREGNANCY TEST JHI ABBOTT LABORATORIES NA 32917M300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN