BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO ADVANTAGE BY NDC URINE PREGNANCY CASSETTE

    MDR report key: 2070756 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00836
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULT VS. SERUM QUANTITATIVE RESULT. A (B)(6), PATIENT, HAD A URINE SAMPLE RUN GIVING A NEGATIVE RESULT. THE DOCTOR QUESTIONED THE RESULTS AND A SUBSEQUENT BLOOD DRAW THAT AFTERNOON RESULTED IN A SERUM QUANT HCG OF 800MIU/ML AND DIAGNOSIS OF ECTOPIC PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO ADVANTAGE BY NDC URINE PREGNANCY CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. P080063 HCG0070142

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR