BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP ONE STEP HCG PREGNANCY TEST

    MDR report key: 2070705 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00816
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    September 21, 2010
    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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE HCG RESULTS. PATIENT 1: URINE TEST AT 1100, (B)(6) TEST AT 1130, CONFIRMED PREGNANCY, DID NOT USE FIRST MORNING URINE SAMPLE. MISCARRIAGE AT 5/40. PT FIT AND WELL ON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP ONE STEP HCG PREGNANCY TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102 HCG0050288

    Patients

    Seq Age Sex Outcome Treatment
    1