BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1100183 · Received July 30, 2008

    Report

    Report Number
    2122870-2008-00234
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS BEFORE THIS EVENT AND SOME PROBLEMS WERE NOTED AFTER THE EVENT. A DIAGNOSTIC SYSTEM CHECK FAILED AFTER THE ERRONEOUS RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS IN 2008. FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) SINCE THAT WAS DUE AND THE SYSTEM CHECK FAILED. FSE SAW BOTH PUMPS WERE DRAWING IN AIR AND FOUND THE BUFFER SUPPLY TUBING INSIDE THE INSTRUMENT WAS CRACKED IN A FEW PLACES AND WAS STIFF. FSE REPLACED THAT TUBING AND HARDWARE VERIFICATION TESTING PASSED WITHIN SPECIFICATIONS. EVEN THOUGH TSH RESULTS ARE UNLIKELY TO BE THE BASIS TO INITIATE OR WITHHOLD TREATMENT, IN THIS EVENT THE HARDWARE FAILURES COULD HAVE AFFECTED OTHER PIVOTAL ASSAYS. DUE TO A POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW TSH RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR SEVERAL PATIENTS. RESULTS REPEATED ON ANOTHER INSTRUMENT WERE BELIEVABLE. HOWEVER, NO DATA HAS BEEN SUPPLIED TO DATE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA