BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1908443 · Received November 27, 2010

    Report

    Report Number
    2122870-2010-00803
    Event Type
    Malfunction
    Date Received
    November 27, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES ON THE DAY OF THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. THIS ACCESS 2 HAD BEEN RECENTLY BEEN REMOVED FROM AN INTEGRATED SYSTEM AND MOVED ACROSS THE LABORATORY. THE CUSTOMER BELIEVES THIS WAS A CONTRIBUTING FACTOR FOR THIS EVENT. THE CUSTOMER RECALIBRATED ACCUTNI AND THE TESTING PRODUCED EXPECTED PATIENT RESULTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. 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 LOW TROPONIN (ACCUTNI) RESULT OF 0.02 NG/ML FOR ONE PATIENT GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TEST PRODUCED A RESULT OF 0.07 NG/ML WITHIN THE RISK STRATIFICATION RANGE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. NOTE: THE NORMAL REFERENCE RANGE IS 0 - 0.04 NG/ML, AND AMI CUTOFF IS 0.50 NG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1