BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2230321 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04951
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    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 FOR THIS EVENT. SERVICE COULD NOT DUPLICATE THE ISSUE. THE FIELD SERVICE ENGINEER EXECUTED ION-SELECTIVE ELECTRODE PERFORMANCE TESTING. ALL RESULTS MET ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, LOW SODIUM (NA), CHLORIDE (CL) AND CALCIUM (CALC) RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR FOUR PATIENTS. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER UPON AWARENESS OF THE ISSUE, THE SAMPLES WERE RERUN ON ANOTHER INSTRUMENT. THE REPEAT RESULTS WERE HIGHER, CONSIDERED AS VALID AND AMENDED REPORTS WERE ISSUED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT CHEMISTRY QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THE EVENT. NO PATIENT SPECIFIC INFORMATION OR SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1