BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1821430 · Received August 31, 2010

    Report

    Report Number
    2050012-2010-00632
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 31, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) AND SYSTEM CHECKS HAVE BEEN RECOVERED APPROPRIATELY. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ONTO LOCATION AND PERFORMED ROUTINE CTA (CLOSED TUBE ALIQUOTTER) REPAIRS IN ADDITION TO TROUBLESHOOTING SAMPLE HANDLING AND CENTRIFUGATION ISSUES. REPLACED THE ALIQUOT PROBE AND REPAIRED THE PUMP BOX. INCREASED THE CENTRIFUGATION TIME DUE TO OBSERVATIONS OF CELLS AND DEBRIS IN SAMPLE SERUM. THE ROOT CAUSE IS UNKNOWN FOR THIS EVENT AT THIS TIME; INVESTIGATION IS CONTINUING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULTS FOR MULTIPLE PATIENT SPECIMENS (RESULTS RANGING BETWEEN 0.6 NG/ML - 1.22 NG/ML). UPON REPEAT, ALL SAMPLES WERE RERUN AND ALL WERE RECOVERED BELOW. ONE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED BASED ON HIGH TROPONIN RESULT. THERE WAS NO DEATH OR INJURY AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1