BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2233758 · Received September 3, 2011

    Report

    Report Number
    2122870-2011-03367
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 9, 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

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011, FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED AN INSTRUMENT DIAGNOSTIC HIGH SENSITIVITY SYSTEM CHECK, DILUTIONS TEST AND PRECISION TEST. ALL RESULTS WERE WITHIN SPECIFICATIONS. THE INSTRUMENT ALIGNMENTS WERE VERIFIED AND FOUND TO BE WITHIN SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. NO FAILURE WAS DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(4) 2011, ERRONEOUS, ELEVATED VITAMIN B12 RESULTS WERE GENERATED ON AN UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS. THE INITIAL VITAMIN B12 RESULTS WERE RELEASED FROM THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER PROVIDED DATA WHICH INDICATED THE GENERATION OF MULTIPLE PATIENT VITAMIN B12 INITIAL AND REPEAT RESULTS ON (B)(4) 2011. HOWEVER ONLY TWO RESULTS DIFFERED FROM THE ORIGINAL RESULT BY MORE THAN 20%, CROSSED THE UPPER LIMIT OF THE EXPECTED VALUES RANGE, AND WAS CONSIDERED ERRONEOUS. ALL OTHER RESULTS IN PROVIDED DATA WERE NOT REGARDED AS ERRONEOUS. INSTRUMENT VITAMIN B12 QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATION PRIOR TO THE EVENT, HOWEVER WAS ABOVE ESTABLISHED SPECIFICATIONS FOR LEVEL THREE QC RESULTS AFTER THE EVENT. A SYSTEM CHECK PERFORMED PRIOR TO, AND AFTER, THE EVENT MET CUSTOMER ESTABLISHED SPECIFICATIONS. THE SAMPLES WERE COLLECTED IN SST TUBES, AND WERE NORMAL IN APPEARANCE WITH NO VISIBLE ABNORMALITIES.

    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 ACCESS VITAMIN B12 REAGENT