BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 882123 · Received July 17, 2007

    Report

    Report Number
    2122870-2007-00160
    Event Type
    Other
    Date Received
    July 17, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 17, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS, BUT ACTUAL DATA WAS NOT SUPPLIED. THE SPECIMENS WERE COLLECTED IN BD, SST TUBES WITH GEL AND CENTRIFUGED AT 3,200 RPM FOR 10 MINUTES AT AMBIENT TEMPERATURE. THE CUSTOMER BELIEVES THE SAMPLES WERE ALLOWED TO CLOT FOR THE APPROPRIATE AMOUNT OF TIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB IN 2007: A) THE FSE PERFORMED SERVICE PROTOCOL. B) THE FSE CONDUCTED DIAGNOSTIC TESTING WHICH MET SPECIFICATIONS. C) THE FSE CHECKED MIXER SPEED AND TRANSDUCER VOLTAGE, AND BOTH WERE WITHIN SPECIFICATIONS. D) THE FSE PERFORMED CARRYOVER CHECK WHICH PASSED. CARDIAC QC PERFORMED BY THE CUSTOMER WAS WITHIN RANGE. 5. IN A FOLLOW-UP IN 2007, NO FURTHER ISSUES WERE REPORTED IN REGARDS TO THIS EVENT. 6. THE CUSTOMER INDICATED THAT THE LAB WILL PAY MORE ATTENTION TO SAMPLE INTEGRITY. A) BECKMAN COULTER INC. (BCI) OFFERED PRE-ANALYTICAL SAMPLE HANDLING INFO AND CUSTOMER DECLINED. 7. NO INSTRUMENT ISSUES WERE IDENTIFIED AND A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. PT A AND B SAMPLES WERE TESTED FOR ACCU TNI AND RESULTS OF 8.6NG/ML AND 25.3 NG/ML WERE OBTAINED RESPECTIVELY. THE ACCU TNI RESULTS WERE NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES OF BOTH PTS WERE RE-TESTED AND THE REPEATED RESULTS WERE LOWER. 0.02 NG/ML FOR PT A AND 0.1 NG/ML FOR PT B. IN ADDITION, THE ORIGINAL SAMPLE OF PT B WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF "~0.1 NG/ML" WAS OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR