BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2230278 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04952
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ONE IS A (B)(6) FEMALE, PATIENT TWO IS A (B)(6) MALE, PATIENT THREE IS A (B)(6) MALE. SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THIS ISSUE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE AND SAMPLE SYRINGE. 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 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE 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 TWO PATIENT SAMPLES WITH ERRONEOUSLY HIGH TG RESULTS WERE GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. UPON REPEAT THE RESULTS WERE LOWER. FOR ONE PATIENT SAMPLE THE INITIAL TG RESULT WAS NOT PROVIDED. ONLY THE REPEAT RESULT WAS SUPPLIED BY THE CUSTOMER. INSTRUMENT ASSAY QUALITY CONTROL (QC) RESULTS FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATION AFTER THE INITIAL RESULTS WERE GENERATED. INSTRUMENT CALIBRATION ASSESSMENTS FAILED TO MEET ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT. AFTER NUMEROUS CALIBRATIONS ATTEMPTS, ACCEPTABLE RESULTS WERE GENERATED AND INSTRUMENT OPERATION WAS RESUMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1