BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1028600 · Received April 10, 2008

    Report

    Report Number
    2122870-2008-00117
    Event Type
    Malfunction
    Date Received
    April 10, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND SYSTEM CHECK WERE WITHIN SPECS BEFORE THIS EVENT. THE SPECIMENS WERE COLLECTED IN LITHIUM HEPARIN TUBES WITH GEL AND CENTRIFUGED AT 3,500 RPM FOR 5 MINS. BD PRODUCT INSERT RECOMMENDS SAMPLES TO BE CENTRIFUGED FOR 10 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DID NOT FIND ANY HARDWARE RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ALL VERIFICATION TESTING PASSED WITHIN SPECS. PRE-ANALYTICAL SAMPLE HANDLING WAS DISCUSSED WITH THE CUSTOMER, AND THE FSE GAVE THEM LITERATURE TO DISTRIBUTE TO ALL OF STAFF AND THE ER FOR FUTURE REFERENCE. PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT FOR A SINGLE PT SAMPLE. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 14.0NG/ML WAS OBTAINED. BECAUSE OF A SIMILAR EVENT IN THE PAST, CUSTOMER COLLECTED A FRESH SAMPLE FROM THE PT, ENSURING THE SAMPLE INTEGRITY. THE NEW SAMPLE GAVE A RESULT OF 0.03NG/ML AND WAS REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY OR CHANGE TO PT TREATMENT HAVE BEEN RECEIVED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA