BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULT DIAGNOSTICS HCG CASSETTE

    MDR report key: 3050185 · Received April 4, 2013

    Report

    Report Number
    2027969-2013-00278
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS ON TWO PATIENTS WITH CONSULT DIAGNOSTICS HCG CASSETTE. POTENTIAL FALSE NEGATIVE URINE HCG RESULTS WERE REPORTED ON TWO PATIENTS WHEN TESTING WITH CONSULT DIAGNOSTICS HCG CASSETTE. AT LEAST ONE OF THE PATIENTS VISITED THE CLINIC TO CONFIRM HOME PREGNANCY TEST RESULTS. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO INFORMATION AS TO WHETHER CONFIRMATION TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137518 CONSULT DIAGNOSTICS HCG CASSETTE HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A102-OBC554 HCG2090061

    Patients

    Seq Age Sex Outcome Treatment
    1