BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 3131652 · Received May 29, 2013

    Report

    Report Number
    2050012-2013-00364
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE CREM MODULE, AND CALIBRATED THE LAMP AND CUP TO RESOLVE THE ISSUE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE APPEARS TO BE THE CREATININE MODULE AND REPLACEMENT OF THE MODULE RESOLVED THE ISSUE. RESULTS: CREATININE MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(4) 2013 THAT THE STIR BAR IN THE CREATININE CUP MODULE OF THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM WAS NOT TURNING. UPON FOLLOW-UP BY A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ON (B)(4) 2013, THE CUSTOMER STATED THAT TWO (2) FALSE HIGH CREM (MODULAR CREATININE) RESULTS WERE GENERATED AND REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPEATED THE PATIENT SAMPLES ON AN ALTERNATE DXC INSTRUMENT AND ISSUED AMENDED REPORTS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. LEVEL 3 QC (QUALITY CONTROL) RESULTS EXHIBITED IMPRECISION. NO OTHER CHEMISTRIES WERE AFFECTED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237318 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1