BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2233749 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04953
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THIS ISSUE. THE FIELD SERVICE ENGINEER (FSE) EXECUTED A PERFORMANCE VERIFICATION CARRYOVER TEST WHICH FAILED TO MEET SPECIFICATION. THE FSE REPLACED THE SAMPLE PROBE, COLLAR WASH AND COLLAR WASH VERTICAL MOUNTING. THE ROOT CAUSE OF THIS EVENT APPEARS TO BE CARRYOVER DUE TO HARDWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, HIGH TRIGLYCERIDE (TG) RESULTS WERE GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR EIGHTEEN PATIENT SAMPLES. THE RESULTS WERE REPEATED ON ANOTHER INSTRUMENT AND RECOVERED LOWER, WERE REGARDED AS VALID, AND REPORTED OUT OF THE LABORATORY. THE INITIAL, ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. CUSTOMER SUPPLIED DATA INDICATED EIGHTEEN PATIENT SAMPLES WITH ERRONEOUSLY HIGH TG RESULTS WERE GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM. UPON REPEAT THE RESULTS WERE LOWER. FOR TWO PATIENT SAMPLES, THE REPEAT TG RESULTS WERE NOT DISTINGUISHABLE FROM THE PATIENT SUPPLIED PRINTOUT. INSTRUMENT ASSAY LEVEL 1 QUALITY CONTROL (QC) RESULTS FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATION ON THE DAY OF THE EVENT HOWEVER LEVEL 2 AND 3 INSTRUMENT ASSAY QC RESULTS MET CUSTOMER ESTABLISHED SPECIFICATIONS. INSTRUMENT CALIBRATION ASSESSMENTS MET ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT, HOWEVER DEMONSTRATED A LOWER THAN NORMAL CALIBRATION FACTOR. THE SAMPLES WERE SERUM SAMPLES. NO ADDITIONAL SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1