BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG URINE CASSETTE

    MDR report key: 3943559 · Received April 30, 2014

    Report

    Report Number
    2027969-2014-00388
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE HCG USING HCG URINE CASSETTE; DURING A CLINICAL TRIAL ON WOMEN AT 38 WEEKS PREGNANT, 20 WEEKS PREGNANT, AND SEVERAL DAYS POST-PARTUM. SMOKING CESSATION CLINICAL TRIAL ON POST-PARTUM WOMEN - STUDY RUN SAME TESTS PRE AND POST BIRTH, WHICH IS THE REASON WHY TEST WAS DONE ON CLEARLY PREGNANT WOMEN. CUSTOMER DOES NOT RUN EXTERNAL LIQUID CONTROLS. THERE WAS NO REPORTED ADVERSE EVENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258585 HCG URINE CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-OBW01 HCG2050294

    Patients

    Seq Age Sex Outcome Treatment
    1