BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1890368 · Received November 3, 2010

    Report

    Report Number
    2122870-2010-00699
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS ACCUTNI SAMPLES IN LITHIUM HEPARIN PLASMA TUBES. SPECIMENS ARE CENTRIFUGED AT 3,200 RPM FOR 10 MINUTES. LEVEL I QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. LEVEL III QC WAS OUT OF RANGE HIGH ON THE DAY OF THE EVENT. HOWEVER, IT IS UNKNOWN IF QC WAS OUT OF RANGE BEFORE OR AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A REAGENT STORAGE COVER REPLACEMENT AND ALL NECESSARY ALIGNMENTS. THE FSE VERIFIED PIPETTOR ULTRASONICS; NO ISSUES WERE NOTED. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, CARRYOVER TEST AND A DIL-TEST; ALL TESTING PASSED WITH INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED ASSAY QC; NO ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR THREE PATIENTS. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL THREE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1