BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 SYSTEM

    MDR report key: 2689824 · Received August 9, 2012

    Report

    Report Number
    2122870-2012-01643
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND DRIED WASH BUFFER IN THE INCUBATOR TRACK AND THE WASH WHEEL OF THE INSTRUMENT. THE FSE PERFORMED PREVENTIVE MAINTENANCE ON THE INSTRUMENT. AFTER COMPLETION OF THE NECESSARY AND VERIFIED ACTIVITIES THE INSTRUMENT WAS RETURNED INTO OPERATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, WAS GENERATED ON AN SYNCHRON LXI 725 SYSTEM FOR A SINGLE PATIENT SAMPLE. THE PATIENT SAMPLE WAS RE-TESTED AND THE REPEAT RESULTS WERE REPRODUCIBLE WITHIN THE SAME CLINICAL RANGE, HOWEVER, COLLECTIVELY THE RESULTS EXCEEDED THE LABELED ACCUTNI ASSAY PRECISION CLAIMS. THE SAMPLE WAS SUBSEQUENTLY REPEAT TESTED IN DUPLICATE ON AN ALTERNATE INSTRUMENT, WHERE REPRODUCIBLE RESULTS WERE GENERATED THAT WERE REGARDED AS VALID. ONE OF THE RESULTS GENERATED FROM THE ALTERNATE INSTRUMENT WAS REPORTED OUTSIDE OF THE LABORATORY. NONE OF THE IMPRECISE ACCUTNI RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN GEL SEPARATOR TUBE AND CENTRIFUGED FOR EIGHT MINUTES AT THREE THOUSAND FIVE HUNDRED REVOLUTIONS PER MINUTE AT ROOM TEMPERATURE PRIOR TO TESTING. THE VOLUME AND THE VISIBLE APPEARANCE OF THE SAMPLE ARE UNKNOWN. THE SAMPLE WAS STORED AT ROOM TEMPERATURE AND WAS PROCESSED THROUGH THE CLOSED TUBE ALIQUOTER AND TESTED FROM THE PRIMARY TUBE. ACCUTNI QUALITY CONTROL (QC) RESULTS ON THE DATE OF THE EVENT PERFORMED WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT ROUTINE SYSTEM CHECKS PERFORMED PRIOR TO THE EVENT MET INSTRUMENT SPECIFICATIONS. THERE WERE NO ERRORS POSTED TO THE EVENT LOG IN ASSOCIATION WITH THIS EVENT. THE ACCUTNI REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122818 AND 120792 RESPECTIVELY. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1