BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK

    MDR report key: 2781923 · Received October 5, 2012

    Report

    Report Number
    2027969-2012-01453
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    July 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE URINE HCG RESULTS WITH MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK VS. ULTRASOUND. NEGATIVE RESULTS WERE OBSERVED WHEN URINE TESTING WAS PERFORMED WITH MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK VS. A SONOGRAM SHOWING GESTATIONAL AGE AROUND (B)(6). THE PATIENT'S LAST MENSTRUAL PERIOD WAS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LAB PERFORMANCE HCG URINE TEST-DIPSTICK HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-111-OBN01 HCG2020135

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR