BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2228025 · Received August 30, 2011

    Report

    Report Number
    2122870-2011-03040
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    2050012-10/13/2011-33C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE INSTRUMENT HAD EXPERIENCED REAGENT STORAGE JAM ISSUES A FEW TIMES PER WEEK WHICH HAD, AT LEAST IN ONE INSTANCE, TRIGGERED AN ADDITIONAL SYSTEM ERROR. THE FSE REPLACED THE REAGENT GRIPPER SENSORS AND UPGRADED THE SYSTEM SOFTWARE. THE INSTRUMENT WAS RETURNED INTO SERVICE UPON VERIFICATION OF REPAIRS. THIS EVENT IS CURRENTLY BEING INVESTIGATED BY BECKMAN COULTER INC. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03040, 2122870-2011-03041, 2122870-2011-03042, 2122870-2011-03048, 2122870-2011-03049, 2122870-2011-03050, 2122870-2011-03051.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE THYROID STIMULATING HORMONE (TSH), FERRITIN, VITAMIN B12, ESTRADIOL, FOLATE, PROGESTERONE, AND/OR PROSTATE SPECIFIC ANTIGEN -WHO STANDARD (PSA-WHO) RESULTS WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2011. THIS REPORT IS ONE OF SEVEN AND REPRESENTS THE TWENTY IMPRECISE TSH PATIENT RESULTS ASSOCIATED WITH THIS EVENT. THE INSTRUMENT HAD EXPERIENCED A MALFUNCTION OF UNKNOWN ORIGIN WHICH MANIFESTED IN A SYSTEM GENERATED "TEMPERATURE CONTROL SHUTDOWN" ERROR. THE CUSTOMER WAS ADVISED BY BECKMAN COULTER INC. TO REBOOT THE ANALYTICAL UNIT AND REPEAT ANY PATIENT SAMPLES THAT WERE PERFORMED DURING THE TIMEFRAME OF THE ERROR. UPON VERIFICATION OF PATIENT RESULTS, THE SAME INSTRUMENT GENERATED HIGHER REPEAT TSH RESULTS, WHICH WERE WITHIN THE SAME CLINICAL CATEGORY, BUT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM. THE IMPRECISE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLES WERE COLLECTED IN SERUM TUBES WITH GEL SEPARATORS AND WERE CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING. PATIENT SPECIFIC INFORMATION, INSTRUMENT QUALITY CONTROL RESULTS AND SYSTEM CHECK INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYPERSENSITIVE HTSH REAGENT