BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG

    MDR report key: 166040 · Received May 1, 1998

    Report

    Report Number
    1451914-1998-00006
    Event Type
    Malfunction
    Date Received
    May 1, 1998
    Date of Event
    March 1, 1998
    Report Date
    April 29, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURN DISCS AND SAMPLE WERE REQUESTED BUT NOT RECEIVED. ABBOTT IN-HOUSE REACTION DISCS FROM LOT NUMBER 3600M300 WERE EVALUATED. THE IN-HOUSE REACTION DISCS MET ACCEPTANCE CRITERIA WHEN TESTED WITH IN-HOUSE PANELS. WITHOUT THE RETURNED REACTION DISCS OR SAMPLE IT CANNOT BE DETERMINED IF THE COMPLAINT IS KIT/SAMPLE RELATED. THE COMPLAINT IS NOT CONFIRMED. EVALUATION COMPLETE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    SERUM SAMPLE WAS NEGATIVE WITH TESTPACK PLUS HCG COMBO OBC. PHYSICIAN QUESTIONED RESULT. THE SAME SAMPLE WAS RUN ON OPUS GIVING AN HCG RESULT OF 400 IU/L. NO ULTRASOUND WAS PERFORMED SINCE THIS WAS CONSIDERED A NORMAL PREGNANCY. NO PT INFO WAS AVAILABLE.

    Description of Event or Problem · 2

    A SERUM SAMPLE WAS NEGATIVE WITH TESTPACK PLUS HCG COMBO OBC. THE SAMPLE WAS THEN RUN ON OPUS GIVING AN HCG RESULT OF 70 IU/L. A URINE TEST (TECHNIQUE UNK) WAS ALSO PERFORMED ON THIS PATIENT AND WAS POSITIVE. NO PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 UNKNOWN