BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2172539 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01943
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 23, 2008
    Report Date
    February 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) WAS NOT DISPATCHED TO THE SITE TO INVESTIGATE THE INSTRUMENT. THE BCI CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO TROUBLESHOOT THE INSTRUMENT. THROUGH THE TROUBLESHOOTING, THE CUSTOMER FOUND A CONTAMINATED SUBSTRATE. THE CUSTOMER PERFORMED THE DECONTAMINATION PROCEDURE WITH PASSING RESULTS. CUSTOMER INDICATED THAT THE SYS IS FUNCTIONING ACCORDING TO SPEC. THE ROOT CAUSE FOR THIS EVENT IS SUBSTRATE CONTAMINATION. THIS IS TWO OF TWO SEPARATE MDR REPORTS RELATED TO TWO PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01942 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 1/1/2008 AND 10/23/2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUS ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE SYNCHRON LX I 725 CLINICAL SYS. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLE WAS RETESTED ON ANOTHER INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CORRECTED RESULTS WERE REPORTED OUTSIDE THE LAB. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI