BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1832595 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00526
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 13, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LI HEPARIN PLASMA THAT WERE CENTRIFUGED FOR 10 MINUTES AT ROOM TEMPERATURE. QC PRIOR TO AND AFTER THE EVENT ON (B)(4) 2010 WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES, BUT QC ON (B)(4) 2010 WAS OUT OF RANGE HIGH. SYSTEM CHECKS WERE PERFORMED ON (B)(4)2010, (B)(4) 2010, AND (B)(4) 2010. THE RESULTS WERE WITHIN THE SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010. FSE REPLACED AND ADJUSTED A FEW PARTS AND PERFORMED A 50 REPLICATE WASH BUFFER BLANK TEST WHICH PRODUCED ONE FLIER. FSE WAS ON SITE AGAIN ON (B)(4) 2010. FSE REPLACED, CLEANED, AND VERIFIED SOME MORE PARTS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED ON SYNCHRON LXI 725 CLINICAL SYSTEM FOR SIX PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE SYSTEM PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1