BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1973184 · Received January 28, 2011

    Report

    Report Number
    2122870-2011-00167
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 30, 2010
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE, AND WAS CENTRIFUGED FOR 3 MINUTES AT 4000 RCF. THE COLLECTION TUBE WAS FULL AND APPEARED NORMAL. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010 AND PERFORMED A HARDWARE SERVICE ASSAY, WHICH MET THE SPECIFICATIONS. THE FSE REPLACED THE PIPETTOR TIP, WASH TOWER NOZZLE, AND PRECISION PUMP SEALS AS A PRECAUTION. NO HARDWARE ISSUE WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1