BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 25HCG

    MDR report key: 1988955 · Received February 14, 2011

    Report

    Report Number
    2518658-2011-00003
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS URINE. RETAIN DEVICES FROM THE COMPLAINT LOT (0070221) AND ANOTHER LOT (0080220) WERE TESTED BY BCI USING CONTROLS, CONFIRMED POSITIVE CLINICAL URINE SAMPLE AND THE CUSTOMER'S URINE SAMPLE. EXPECTED RESULTS WERE OBTAINED FOR BOTH LOTS. THE TEST LINES ON THE COMPLAINT LOT USING THE URINE SAMPLE WERE WEAKER THAN THE OTHER LOT, BUT WERE STILL READABLE POSITIVE. THE CUSTOMER DID NOT RETURN THE PATIENT SERUM SAMPLE. THE COMPLAINT WAS NOT CONFIRMED AS DEVICES PERFORMED AS EXPECTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT URINE (-) VS. SERUM (+) TEST RESULTS OBTAINED FROM ICON 25 TEST KIT AND OTHER METHOD. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH OR INJURY ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER, INC. NA HCG0070221

    Patients

    Seq Age Sex Outcome Treatment
    1