BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID PLUS HCG URINE/SERUM PREGNANCY

    MDR report key: 1781368 · Received July 30, 2010

    Report

    Report Number
    2027969-2010-01097
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A FALSE NEGATIVE URINE PREGNANCY RESULT. THE FALSE NEGATIVE RESULT WAS CONFIRMED BY A DIFFERENT REFERENCE METHOD WHICH GAVE A POSITIVE RESULT. A FEMALE PT PRESENTED AT THE CLINIC WITH A HISTORY OF PAIN AND BLEEDING; PREGNANCY TESTS PERFORMED BY THE PT AT HOME HAD BEEN POSITIVE. THE PREGNANCY TEST RUN AT THE CLINIC GAVE NEGATIVE RESULTS. DUE TO THE HISTORY AND CLINICAL SUSPICION THE PT WAS SENT FOR AN ULTRASOUND SCAN WHICH SHOWED AN INTRAUTERINE PREGNANCY DATED AS BEING 10 WEEKS AND 2 DAYS GESTATION. THE NEGATIVE RESULT WAS VERIFIED BY SEVERAL LABORATORY STAFF ON THE SAME URINE SAMPLE SUBSEQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUPID PLUS HCG URINE/SERUM PREGNANCY HCG PREGNANCY TEST JHI BIOSITE INCORPORATED FHC-202-ONC44 100551CE

    Patients

    Seq Age Sex Outcome Treatment
    1