BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3251181 · Received July 29, 2013

    Report

    Report Number
    2050012-2013-00504
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER FSE SUSPECTED A SAMPLE CARRYOVER ISSUE AND RETURNED TO THE CUSTOMER'S SITE. THE FSE REPLACED THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE TO RESOLVE THE ISSUE AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE CUSTOMER REPEATED THE AFFECTED PATIENT SAMPLES ON THE ORIGINAL INSTRUMENT AFTER REPLACEMENT OF THE CC SAMPLE PROBE AND ISSUED AMENDED REPORTS OUT OF THE LABORATORY. FAILURE MODE OF THE HIGH MICROALBUMIN RESULTS IS ATTRIBUTED TO THE CC SAMPLE PROBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LEVEL ONE MICROALBUMIN (MA) QUALITY CONTROL (QC) RESULT HAD SHIFTED HIGH AND WAS OUT OF THE ESTABLISHED RANGE FOR THE UNICEL DXC 800 SYNCHRON SYSTEM. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND REPLACED THE MA CALIBRATOR AND REAGENT. THE CUSTOMER CALLED BACK STATING THAT THE LEVEL 1 QC HAD SHIFTED HIGH AGAIN AFTER A SERIES OF SERUM SAMPLE RUN. THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH MICROALBUMIN (MA) RESULTS FOR FIVE (5) PATIENT SAMPLES. THE INITIAL RESULTS WERE REPORTED OUT OF THE LABORATORY BUT WERE LATER AMENDED. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE BECKMAN COULTER FSE WAS DISPATCHED AGAIN TO THE CUSTOMER'S SITE. THE CUSTOMER DID NOT REPORT OF ANY SAMPLE PREANALYTICAL ISSUE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353585 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1