BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25HCG

    MDR report key: 2133050 · Received June 18, 2011

    Report

    Report Number
    2518658-2011-00011
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS WHOLE BLOOD SERUM. CONTROLS ARE RUN EVERY TIME A NEW BOX IS OPENED. TECHNICIAN DID NOT NOTE ANYTHING UNUSUAL WITH THE PATIENT URINE SAMPLES. INVESTIGATION BY SHARON HILL QC WITH RETAINS AND RETURN DEVICES USING CONTROLS, PATIENT SERUM SAMPLES, AND CONFIRMED POSITIVE CLINICAL URINE SAMPLES (49 MIU/ML AND 72000 MIU/ML) GAVE EXPECTED RESULTS. CUSTOMER DID NOT RETURN THE PATIENT URINE SAMPLES. COMPLAINT NOT CONFIRMED, AS DEVICES PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THREE DISCREPANT (+) SERUM VS. (-) SERUM URINE QUALITATIVE TEST RESULTS OBTAINED FROM THE ICON 25 TEST KIT. ON ONE OF THE THREE INSTANCES, THEY GOT A FAINT POSITIVE. THE OTHER WAS REPEATED TWICE AND WAS TOTALLY NEGATIVE. THE THIRD SAMPLE WAS COMPLETELY NEGATIVE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER INC HICON 25 HCG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1