BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE

    MDR report key: 1934002 · Received December 1, 2010

    Report

    Report Number
    2027969-2010-02097
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED THAT CUSTOMER HAD ONE PT WHO OBSERVED TWO POSITIVE HCG RESULTS ON HOME PREGNANCY TESTS. WHEN TESTING WAS PERFORMED IN THE CUSTOMER'S FACILITY, NEGATIVE RESULTS WERE OBSERVED USING MEDI-LAB PERFORMANCE HCG COMBO TEST. A REPEAT ALSO GAVE NEGATIVE RESULTS. A SERUM HCG WAS SENT TO THE LAB WITH POSITIVE RESULT OF 317.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202-OBW12 HCG0010244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention