BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS

    MDR report key: 1235760 · Received November 18, 2008

    Report

    Report Number
    2050012-2008-00073
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. TREATMENT WAS NOT IMPACTED IN THIS EVENT BECAUSE THE PHYSICIAN QUESTIONED THE RESULT. UPON RECUR, TREATMENT COULD BE INITIATED BASED ON THE FALSELY ELEVATED MG RESULT OBTAINED. TREATMENT INITIATED ON FALSELY ELEVATED MG RESULT COULD CONTRIBUTE TO SERIOUS INJURY. NO ADDITIONAL INFO REGARDING THIS VENT IS AVAILABLE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING HIGH MAGNESIUM (MG) RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS FOR ONE PT SAMPLE. A PT SAMPLE WITH INCORRECT RESULTS INITIALLY FLAGGED "OIR HI" WAS DILUTED 1:2 AND STILL WAS FLAGGED "OIR HI". (OIR- OUT OF INSTRUMENT RANGE). THE CUSTOMER THEN MADE A DILUTION 1:3 AND A RESULT OF 16.9MG/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH EARLIER RESULTS OF 9.0MG/DL AND 10.1MG/DL. PER CUSTOMER, THEY RERAN THE SAMPLE FOR MG ON TWO DIFFERENT INSTRUMENTS AND RESULTS WERE 8.6MG/DL AND 8.7MG/DL. IT IS UNK WHETHER THESE SAMPLES WERE RUN DILUTED. PT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA