BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1993836 · Received February 16, 2011

    Report

    Report Number
    2122870-2011-00397
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED AT 3500 RPM FOR 10 MINUTES. THE SAMPLE WAS ASPIRATED FROM THE COLLECTION TUBE VIA THE CLOSED TUBE ALIQUOTTER (CTA). QC WAS WITHIN THE ESTABLISHED RANGES ON THE DAY OF THE EVENT. THE SYSTEM CHECK PASSED WITHIN THE SPECIFICATIONS. SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT, AND THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM). ALL VERIFICATION TESTING MET THE SPECIFICATIONS, AND THE FSE STATED THERE WAS NO HARDWARE ISSUE. 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 CKMB RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS CONCERNED ABOUT THE DIFFERENCES BETWEEN THE RESULTS FROM THE SAME SAMPLE. 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 JLB BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1