BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2162979 · Received July 15, 2011

    Report

    Report Number
    2122870-2011-02274
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED SERVICE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRATIC THYROID STIMULATING HORMONE (TSH) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. DATA PROVIDED BY THE CUSTOMER INDICATED THE GENERATION ON ONE PATIENT SAMPLE TSH RESULT WHICH WAS WITHIN THE NORMAL REFERENCE RANGE. UPON REPEAT ON THE SAME INSTRUMENT DAYS LATER, THE SAME SAMPLE GENERATED TWO LOWER TSH RESULTS WITHIN THE NORMAL REFERENCE RANGE. THESE REPEAT RESULTS WERE ACCEPTED BY THE CUSTOMER AS VALID. ALTHOUGH THESE RESULTS MAY HAVE BEEN REPORTED OUT OF THE LABORATORY THERE WAS NO DEATH SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. IT IS NOT KNOWN, WHICH RESULTS WERE REPORTED OUT OF THE LABORATORY. NO SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER. THE TSH SAMPLE WAS A PLASMA SAMPLE. NO ADDITIONAL PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYPERSENSITIVE HTSH REAGENT