BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2314049 · Received October 28, 2011

    Report

    Report Number
    2050012-2011-06225
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 23, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CER
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS RUN BEFORE AND AFTER THE INCIDENT WERE WITHIN ESTABLISHED RANGES. THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTED TO SAMPLE INTERFERENCE (ETHYLENE GLYCOL).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A SUPPRESSED LACTATE (LACT) RESULT WITH RX ABS HI (REACTION ABSORBANCE HIGH) FLAG GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM ON A NEAT SAMPLE DRAW FROM A PATIENT THAT WAS INTOXICATED WITH ETHYLENE GLYCOL. THE LAB TECHNICIAN DILUTED THE SAMPLE AND THE RESULT YIELDED A VALUE OF 4.1MMOL/L. THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AROUND MIDNIGHT OF (B)(6) 2011. IN THE MORNING OF (B)(6) 2011, THE LAB TECHNICIAN NOTIFIED THE BIOCHEMIST OF THE RESULTS AND THE BIOCHEMIST INSTRUCTED THE LAB TECHNICIAN TO RERUN THE SAMPLE WITH MULTIPLE DILUTIONS. WHEN THE BIOCHEMIST WAS NOTIFIED THAT THE PATIENT WAS INTOXICATED WITH ETHYLENE GLYCOL, HE REVIEWED THE DATA AND MANUALLY CALCULATED THE LACT RESULT WHICH YIELDED A VALUE OF 2.0 MMOL/L AND AMENDED THE ORIGINAL RESULT. THE BIOCHEMIST CONCLUDED THAT GLYCOLIC ACID COULD HAVE INTERFERED WITH THE LACTATE REACTION. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. PER THE CUSTOMER'S LABORATORY REFERENCE INTERVALS, BOTH THE ORIGINAL AND AMENDED RESULTS WERE WITHIN THE NORMAL RANGES. THERE WAS NO IMPACT TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1