BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEST HCG

    MDR report key: 930385 · Received October 19, 2007

    Report

    Report Number
    2432235-2007-00038
    Event Type
    Other
    Date Received
    October 19, 2007
    Date of Event
    August 24, 2007
    Report Date
    August 24, 2007
    Manufacturer
    WAMPOLE LABORATORIES, LLC.
    Product Code
    JHI
    PMA / PMN Number
    K023944
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL EVALUATION OF CLINITEST HCG LOT 97266 WAS COMPLETED USING NEGATIVE URINE. A PERCENTAGE OF FALSE POSITIVES WAS OBSERVED, WHICH WAS DEEMED INTERNALLY AS UNACCEPTABLE, IN ADDITION, VISUAL INSPECTION OF DISASSEMBLED CASSETTES CONFIRMED A MANUFACTURING STRIP ALIGNMENT ISSUE. AS A RESULT, SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS HAS ISSUED A FIELD CORRECTION CUSTOMER BULLETIN TO INFORM CUSTOMERS AND ADVISE THEM OF REQUIRED ACTION. PLEASE REFER TO THE CUSTOMER BULLETIN ATTACHED TO THIS REPORT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER STATED, PATIENT WAS ADMITTED WITH ACUTE ABDOMINAL PAIN. PATIENT URINE WAS TESTED USING CLINITEST HCG ON THE CLINITEK STATUS INSTRUMENT. CUSTOMER STATED, PATIENT INITIAL RESULT WAS POSITIVE AS WELL AS RE-TEST. RESULTS WERE RELEASED. SINCE EXTRAUTERINE PREGNANCY WAS SUSPECT, PATIENT UNDERWENT LAPAROSCOPY PROCEDURE WHICH CONFIRMED NO PREGNANCY IN UTERUS. CUSTOMER STATED, THAT URINE SAMPLE WAS LATER CONFIRMED NEGATIVE USING AN ALTERNATE METHOD. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEST HCG PREGNANCY TEST (QUALITATIVE) JHI WAMPOLE LABORATORIES, LLC. 97266

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other