BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2213763 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-03999
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE PATIENT SAMPLES WERE COLLECTED AT TROUGH OR AT PEAK LEVEL INTERVALS FOR THE VANC CHEMISTRY. CONTROLS WERE RUN BEFORE THIS INCIDENT AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. THE CUSTOMER INDICATED THAT THERE IS NO ISSUE WITH THE INSTRUMENT, THUS THIS EVENT APPEARS TO BE A PATIENT SPECIFIC ISSUE. SERVICE WAS NOT REQUESTED FOR THIS EVENT. THIS REPORT IS RELATED TO MDR 2050012-2011-04000 THAT IS REPORTING ON A DIFFERENT DATE, FOR THE SAME PATIENT, AND FOR A SIMILAR EVENT THAT OCCURRED AT THIS CUSTOMER SITE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSE VANCOMYCIN (VANC) RESULT, WHICH YIELDED A SUPPRESSED RESULT WITH A FLAGGED - REACTION ABSORBANCE HIGH FLAG, ON ONE (1) NEAT SAMPLE FROM A SINGLE PATIENT GENERATED BY THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THE LABORATORY TECHNICIAN DILUTED THE SAMPLE UP TO 1:4 DILUTION AND RECEIVED A RESULT OF <3.5 UG/ML. THE LABORATORY TECHNICIAN QUESTIONED THE RESULTS AND NO REPORTS WERE SUBMITTED OUT OF THE LABORATORY. THE CUSTOMER SENT THE PATIENT SAMPLE TO A REFERENCE LABORATORY AND YIELDED A RESULT OF 25 UG/ML, WHICH WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT THE PATIENT HAS BEEN ON VANC TREATMENT FOR 10 DAYS DURING THE TIME OF THE EVENT. AFFECT TO PATIENT TREATMENT IS UNKNOWN. ACCORDING TO THE CUSTOMER, BASED ON THE RESULTS FROM THE REFERENCE LAB, THE PHYSICIAN MAY HAVE INCREASED THE VANC DOSAGE PER THE FALSE RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1