BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2951055 · Received February 8, 2013

    Report

    Report Number
    2050012-2013-00090
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 13, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CFR
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IS PROVIDING AN ADDTIONAL INFORMATION FOR MDR #: 2050012-2013-00090, (B)(4). ADDITIONAL INVESTIGATION INFORMATION AND FAILURE MODE CHANGE: THE GLUCOSE OXYGEN SENSOR WAS RETURNED TO BECKMAN COULTER FOR INVESTIGATION. THE XENON LABORATORY COULD NOT CONFIRM THE FAILURE REPORTED BY THE CUSTOMER. THE ELECTRODE PASSED ALL INSTRUMENT TESTING. FAILURE MODE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    QC WAS RUN PRIOR TO THE EVENT AND THE RESULTS WERE WITHIN LAB-ESTABLISHED RANGES. QC PERFORMED AFTER THE EVENT RECOVERED LOW. THE CUSTOMER RECALIBRATED THE INSTRUMENT; HOWEVER, THE CUSTOMER WAS NOT SATISFIED WITH THE RESULTS. THE CUSTOMER THEN REPLACED THE GLUCOSE ELECTRODE WHICH RESOLVED THE ISSUE. SERVICE WAS NOT REQUESTED FOR THIS EVENT. FAILURE MODE OF THIS EVENT WAS GLUCOSE ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, (BEC) THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS GENERATING FALSE LOW GLUCOSE (MODULAR GLUCOSE, GLUCM) RESULTS THAT WERE REPORTED OUTSIDE OF THE LAB. THE CUSTOMER RE-RAN PATIENT SAMPLES ON ANOTHER ANALYZER AND AMENDED 40 PATIENT RESULTS. PER THE CUSTOMER'S KNOWLEDGE, THERE'S NO IMPACT TO PATIENT TREATMENT BASED ON THE FALSE LOW REPORTED RESULTS. REVIEW OF THE CUSTOMER DATA SHOWS THIRTY NINE (39) FALSE LOW PATIENT SAMPLES (THE 2ND SAMPLE - THE LAST SAMPLE). THE DIFFERENCES IN THE ORIGINAL AND THE AMENDED RESULTS FOR THE FIRST PATIENT IN THE ATTACHED DATA IS WITHIN THE PRECISION RANGE OF 2 SD, AND NOT ERRONEOUS (PER GLUCM CHEMISTRY INFORMATION SHEET (CIS), 2SD = 6.0MG/DL). AN INCORRECT RESULT FOR THIS PATIENT WAS 92MG/DL, THE CORRECT RESULT WAS 97MG/DL. THE FILE IN THE ATTACHMENT CONTAINS THE ORIGINAL AND THE AMENDED RESULTS FOR 40 PATIENTS. UNITS OF MEASURE OF GLUCM RESULTS IS MG/DL. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54853 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CFR BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1