BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1203156 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00328
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC DATA WAS NOT SUPPLIED; HOWEVER, BASED ON THE INITIAL INFO, THE INSTRUMENT WAS PERFORMING WITHIN QC SPECIFICATIONS. THE SPECIMENS WERE COLLECTED IN 13 X 100 GREINER, SST TUBES. AN APPLICATIONS SPECIALIST (AS) WAS IN THE LAB IN 2008: THE AS PERFORMED HARDWARE VERIFICATION AND CONDUCTED INSTRUMENT PERFORMANCE TESTING. ALL RESULTS MET SPECIFICATIONS. THE AS PERFORMED VISUAL INSPECTION OF QUESTIONED PT SAMPLES AND, ALL SPECIMENS WERE CLEAR AND FREE OF DEBRIS. THE AS PERFORMED ACCU TNI REAGENT PACK INVESTIGATION AND NOTED TWO PACKS IN USE ON THE INSTRUMENT HAD FAULTY ELASTOMER SEALS. REMAINING ACCU TNI REAGENT PACK STOCK WAS ALSO INSPECTED AND ADDITIONAL FAULTY ELASTOMER SEALS WERE IDENTIFIED AND REMOVED. IT WAS DISCUSSED WITH THE STAFF TO CHECK ALL REAGENT PACKS BEFORE PLACING ON THE INSTRUMENT. PER AS, THE WEEKLY MAINTENANCE WAS OVERDUE. THE INSTRUMENT FILTERS WERE VERY DIRTY AND CLEANED. CRUSTY BUILD-UP WAS FOUND ON THE BASES OF THE CLOSED TUBE ACCESSING (CTA) SYRINGES, WHICH WERE CLEANED. THE AS PERFORMED WEEKLY MAINTENANCE WITH STAFF ON SITE AND DISCUSSED IMPORTANCE OF CLEANING FILTERS AND CHECKING CTA SYRINGES. 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PT SAMPLES. PT A: THE INITIAL RESULT WAS 3.05NG/ML AND 0.05NG/ML UPON REPEAT. PT B: THE INITIAL RESULT OF 0.70NG/ML WAS REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE ALIQUOT WAS RE-SPUN AND THEN RETESTED, AND A RESULT OF 0.02NG/ML WAS OBTAINED. A CORRECTED REPORT WAS SENT. THERE WAS NO EFFECT TO THE PTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA