BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULT DIAGNOSTICS HCG URINE CASSETTE

    MDR report key: 3252070 · Received July 24, 2013

    Report

    Report Number
    2027969-2013-00625
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HCG RESULTS ON THE CONSULT DIAGNOSTICS HCG URINE CASSETTE TEST. REPORTEDLY, (B)(6), FEMALE PATIENT TESTED NEGATIVE; HOWEVER, WAS (B)(6) WEEKS PREGNANT. THE FOLLOW WAS REPORTED: URINE WAS CLEAR. THE FIRST MORNING URINE WAS NOT USED. UNKNOWN HOW PREGNANCY DIAGNOSIS WAS MADE AS QUANTITATIVE SERUM HCG WAS NOT RUN. LAST MENSTRUAL PERIOD: (B)(6) 2013. THE PATIENT WAS GIVEN A DEPO-PROVERA INJECTION ON (B)(6) 2013 BASED ON THE NEGATIVE HCG RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345879 CONSULT DIAGNOSTICS HCG URINE CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102 HCG1100324

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other