BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 1884377 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00674
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 27, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS LI HEPARIN PLASMA THAT WAS CENTRIFUGED FOR 5 MINUTES AT 5000RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4) 2010. FSE REPLACED THE INDEX SENSOR FOR THE INCUBATOR BELT AND THE CORRESPONDING INTERFACE BOARD. ALL VERIFICATION TESTING MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ELEVATED TROPONIN (ACCUTNI) RESULT OF 3.62NG/ML GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT. UPON REPEAT TESTING, THE RESULT WAS 0.0NG/ML IN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1