BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2250545 · Received September 16, 2011

    Report

    Report Number
    2122870-2011-03580
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS IT WAS BELIEVED TO BE SAMPLE RELATED BECKMAN COULTER INC. REQUESTED THAT THE SAMPLE BE SENT INTO CUSTOMER PRODUCT LINE SUPPORT FOR INVESTIGATIONAL TESTING, OR THAT THE SAMPLE BE SENT TO A REFERENCE LAB TO CONFIRM THE CUSTOMER'S RESULTS. THE CUSTOMER REPORTED THERE WAS NO SAMPLE REMAINING THAT COULD BE SENT OUT FOR TESTING. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03580, 2122870-2011-03581, 2122870-2011-03630.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE THYROID STIMULATING HORMONE (TSH) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES. THIS REPORT IS ONE OF THREE AND REPRESENTS THE INITIAL TSH RESULT GENERATED FOR ONE PATIENT SAMPLE ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2011 WHICH WAS REGARDED AS IMPRECISE. THE INITIAL TSH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY BUT WAS QUESTIONED BY THE PHYSICIAN. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. UPON MULTIPLE REPEAT TSH AND FAST TSH TESTING ON THE SAME INSTRUMENT , THE TSH RESULTS VARIED FROM THE FAST TSH RESULTS. COLLECTIVELY THE RESULTS DID NOT MEET THE PRECISION CLAIMS OF THE ASSAY. REPEAT FAST TSH RESULTS WERE ALSO GENERATED ON ANOTHER INSTRUMENT. THESE RESULTS WERE NOT QUESTIONED AS IMPRECISE BY THE CUSTOMER AS THE MATCHED THE FAST TSH RESULTS OBTAINED ON THE INITIAL INSTRUMENT. THE SAMPLE WAS DRAWN INTO LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED PRIOR TO TESTING. THE SAMPLE WAS RETAINED AT ROOM TEMPERATURE. BECKMAN COULTER LED CUSTOMER TROUBLESHOOTING REVEALED THAT HARDWARE WAS NOT MALFUNCTIONING AND THE ISSUE WAS ISOLATED TO SPECIFIC PATIENT SAMPLES. INSTRUMENT ASSAY QUALITY CONTROL RESULTS WERE RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. NO PATIENT SPECIFIC INFORMATION, ADDITIONAL SAMPLE COLLECTION/HANDLING INFORMATION OR ADDITIONAL INSTRUMENT PERFORMANCE 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