BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3844493 · Received June 3, 2014

    Report

    Report Number
    2050012-2014-00272
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE EVALUATED THE INSTRUMENT AND A LEAK AT THE CAP PIERCER WAS CONFIRMED. THE FSE REMOVED AN OBSTRUCTION IN THE CAP PIERCER WASTE LINE TO CORRECT THE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER HOTLINE SUPPORT THAT SAMPLE TUBES PROCESSED ON THEIR UNICEL® DXC 600I INSTRUMENT APPEARED TO BE WET. TROUBLESHOOTING WITH THE ASSISTANCE OF HOTLINE SUPPORT REVEALED AN OVERFLOWING CAP PIERCER BLADE WASH. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WORE A LAB COAT, GLOVES AND GOGGLES WHILE OPERATING THE INSTRUMENT. THE CUSTOMER ALSO STATED THE OBTAINED ERRONEOUS GLUCOSE RESULTS FOR SEVERAL PATIENTS. A REVIEW OF PATIENT DATA PROVIDED BY THE CUSTOMER WAS PERFORMED AND IT WAS VERIFIED THAT GLUCM (GLUCOSE) RESULTS WERE GENERATED WHICH DO NOT MEET BECKMAN COULTER 2 SD TOTAL PRECISION CLAIMS. THE CUSTOMER RELEASED ERRONEOUS RESULTS FROM THE LABORATORY AND CREATED AMENDED REPORTS. THE CUSTOMER DOES NOT HAVE INFORMATION THAT PATIENT TREATMENT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324029 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1