BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2533358 · Received April 12, 2012

    Report

    Report Number
    2050012-2012-00946
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    March 18, 2012
    Report Date
    March 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REAGENT USED IN CONJUNCTION WITH UNICEL DXC 800 SYNCHRON SYSTEM: CATALOG NO.: 472500; BRAND NAME: GLUCM (GLUCOSE) REAGENT; LOT NUMBER: T103093.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM GENERATED AN ERRONEOUS HIGH GLUCOSE RESULT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE DOCTOR QUESTIONED THE RESULT BECAUSE THE RESULT DID NOT CORRELATE WITH THE FINGER PRICK TEST. CUSTOMER REPORTED THAT THE SAMPLE WAS REPEATED. CUSTOMER REPORTED THAT THE REPEAT PRODUCED A LOWER RESULT. CUSTOMER REPORTED THAT THE GLUCOSE RESULT WAS AMENDED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT BECAUSE BECKMAN COULTER WAS NOTIFIED WEEKS AFTER THE EVENT. BEC FIELD SERVICE DID RUN OTHER GREY TOP FLUORIDE TUBE SAMPLES STORED IN THE LABORATORY TO VERIFY PERFORMANCE AND DID NOT NOTICE ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1