BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE

    MDR report key: 2193329 · Received July 26, 2011

    Report

    Report Number
    2027969-2011-01639
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE HCG RESULTS. PATIENT WAS (B)(6) PREGNANT. PATIENT HAD SURGERY, CAT SCAN AND A CHEST X-RAY THAT DAY. TEST WAS READ AT 3 MINUTES. NO SAMPLE REMAINS. UNKNOWN IF FIRST MORNING SAMPLE WAS USED OR THE COLOR/CLARITY OF THE URINE. QUANT NOT DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LAB PERFORMANCE HCG URINE TEST-CASSETTE HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-102-OBW12 HCG0110249

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other