BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25 HCG (COMBO CASSETTE)

    MDR report key: 2971247 · Received February 1, 2013

    Report

    Report Number
    2027969-2013-00106
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE NEGATIVE URINE HCG TEST RESULT WITH ICON 25 HCG (COMBO CASSETTE) VS. SERUM QUANTITATIVE RESULT. A FEMALE PT CAME INTO THE DOCTOR'S OFFICE BECAUSE HER MENSTRUAL PERIOD WAS LATE AND SHE OBSERVED A POSITIVE ON A HOME PREGNANCY TEST. PTS' URINE GAVE A NEGATIVE RESULT WHEN TESTED WITH THE ICON 25 HCG PREGNANCY TEST. A SERUM QUANTITATIVE TEST WAS ORDERED AND THE RESULT CAME BACK AS 238MIU/ML. BLOOD TEST WILL BE REPEATED TOMORROW, ON (B)(6) 2013, DUE TO PT'S CONCERN ABOUT CONFLICTING RESULTS AND ALSO TO ASSURE THAT PT HAS CONTINUED PREGNANCY, OR THAT THERE IS AN INCREASING HCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45392 ICON 25 HCG (COMBO CASSETTE) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-202 HCG2070308

    Patients

    Seq Age Sex Outcome Treatment
    1