BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1342230 · Received January 23, 2009

    Report

    Report Number
    2122870-2009-00020
    Event Type
    Malfunction
    Date Received
    January 23, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 23, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A SODIUM HEPARIN TUBE AND IT WAS CENTRIFUGED AT AN UNSPECIFIED SPEED FOR 10 MINS. BASED ON AVAILABLE INFO, THE CUSTOMER CALIBRATED NEW ACCU TNI REGENT IN EARLY 2009 THREE TIMES BEFORE OBTAINING ACCEPTABLE RESULTS. QC CHARTS SHOW THE CUSTOMER'S QC SHIFTED HIGH IMMEDIATELY UPON SWITCHING TO THE NEW REAGENT. THE CUSTOMER PERFORMED A SYSTEM CHECK EIGHT DAYS LATER, WHICH FAILED DUE TO QUANTITY NOT SUFFICIENT (QNS) FAGS. THE CUSTOMER DID NOT REPEAT THE SYSTEM CHECK BUT COMMONLY THIS TYPE OF FAILURE IS DUE TO NOT ENOUGH SYSTEM CHECK SOLUTION IN THE SAMPLE CUP. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. 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 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 0.54NG/ML WAS OBTAINED. THE ORIGINAL SAMPLE WAS RE-TESTED SEVERAL TIMES AND REPEATED RESULTS WERE IN THE RANGE OF 0.02-0.04 NG/ML. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. IT IS UNK IF PT TREATMENT WAS AFFECTED 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA