BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3024096 · Received March 27, 2013

    Report

    Report Number
    2050012-2013-00176
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES. THE CUSTOMER REPORTED THAT THE DXC 800 PRO WAS GENERATING CREATININE EA ERRORS (ERRATIC ADC ERRORS). PER INSTRUMENT IFU, ERRATIC ADC (ANALOG-TO-DIGITAL CONVERTOR) FLAG IS AN INDICATION OF MODULAR CUP (MC) NOISE. THE CUSTOMER STATED THAT THEY CORRECTED THE PROBLEM BY REPLACING THE STIR BAR. PER THE CUSTOMER, THE CAUSE OF THE EVENT IS ATTRIBUTED TO THE STIR BAR. THE CUSTOMER DID NOT REQUEST SERVICE AND MENTIONED THAT THE STIR BAR WAS NOT AVAILABLE TO SEND TO BEC FOR EVALUATION. IT IS UNKNOWN OF HOW FREQUENTLY THE CUSTOMER PERFORMS MAINTENANCE. PER INSTRUMENT IFU, THE INSTRUCTION FOR FOUR-MONTH MAINTENANCE INCLUDES THE CLEANING OF THE MC REAGENT LINES, CUPS, AND STIR BARS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT ERRONEOUS CREATININE (CRE) PATIENT RESULTS (BOTH HIGH AND LOW) GENERATED BY A UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER WAS ASKED BUT DID NOT DESCRIBE WHY WERE THE RESULTS BELIEVED TO BE ERRONEOUS. OF THE 13 PATIENT SAMPLES PROVIDED BY THE CUSTOMER, BEC REVIEW SHOWED THAT THE DIFFERENCE BETWEEN THE ORIGINAL AND THE REPEATED RESULTS FOR ONE PATIENT SAMPLE WAS WITHIN THE 2 SD (STANDARD DEVIATION) TOTAL PRECISION CLAIM [ORIGINAL RESULT = 1.6 MG/DL, REPEATED RESULT = 1.2 MG/DL. TOTAL PRECISION CLAIM FOR CRE 2 SD = 0.4 MG/DL]. THEREFORE, THERE WERE A TOTAL OF 12 ERRONEOUS RESULTS. THERE WAS NO INJURY OR AFFECT TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125644 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1