BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 96552 · Received June 3, 1997

    Report

    Report Number
    1451914-1997-00027
    Event Type
    Malfunction
    Date Received
    June 3, 1997
    Date of Event
    April 25, 1997
    Report Date
    June 2, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: REACTIONS DISCS AND SERUM SAMPLE WERE RETURNED FOR TESTING. THE RETURNED SERUM SAMPLE ELICITED A DISTINCT NEGATIVE RESULT AS DEFINED BY REF. PHOTOS WHEN ASSAYED ON RETURNED REACTION DISCS. BOTH MET ACCEPTANCE CRITERIA WHEN TESTED WITH IN-HOUSE PANELS. THE QUANTITATIVE RESULT OF THE RETURNED SERUM SAMPLE WAS 1.88 MLU/ML WHICH IS CONSISTANT WITH THE QUALITATIVE RESULT. EVALUATION COMPLETE-FINAL REPORT.

    Description of Event or Problem · 1

    ON APRIL 25, 1997 THE ACCOUNT OBTAINED DISCREPANT RESULTS WHEN A SERUM SAMPLE WAS TESTED USING TESTPACK HCG COMBO PLUS KIT FOR A DEFINITE POSITIVE RESULT. THE PATIENT WAS RETESTED ON 04/30/1997 USING A SERUM SAMPLE WITH THE SAME KIT LOT NUMBER FOR A WEAK POSITIVE RESULT. THIS WAS PRE-OP PATIENT AND SURGERY SCHEDULED FOR 05/01/1997 WAS CANCELLED. A SERUM QUANTITIATIVE RESULT OF .8MLU/ML WAS OBTAINED USING THE SAME SERUM AND THE IMX INSTRUMENT. THE SAMPLE WAS THEN SENT TO A REFERENCE LAB AND THE RESULT WAS NEGATIVE AT <5. THE REFERENCE LAB METHODOLOGY IS NOT KNOWN. THE PATIENT WAS A WALK-IN AND THE ACCOUNT DOES NOT HAVE ACCESS TO PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-COMBO RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 26613M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other