BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2076435 · Received May 4, 2011

    Report

    Report Number
    2050012-2011-01441
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. USE ERROR LIKELY DUE TO SUSPECTED LOW SAMPLE VOLUME.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) CONTACTED THE CUSTOMER AFTER IT WAS DETERMINED THROUGH INTERNAL MONITORING THAT ONE GLUCOSE RESULT ON A UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS ERRONEOUSLY LOW WHEN RUNNING IN DUPLICATE MODE. IN ADDITION, OTHER ASSAYS FOR THE SAME SAMPLE (I.E., CHLORIDE, CREATININE, PHOSPHORUS, SODIUM, AND TOTAL PROTEIN) GENERATED RESULTS WHICH WERE BELOW THE RESPECTIVE REFERENCE RANGES FOR THESE ANALYTES TESTED. THE CUSTOMER DID NOT CALL BCI TO COMPLAIN ABOUT THE LOW RESULTS OBTAINED. THE INITIAL GLUCOSE RESULT YIELDED 30 MG/DL. A REPEAT ANALYSIS FOR GLUCOSE GENERATED AN EXPECTED RESULT OF 180 MG/DL. ADDITIONAL REPEAT DUPLICATE ANALYSES PERFORMED YIELDED GLUCOSE RESULTS OF 182/182 MG/DL. THE REPEAT ANALYSES FOR THE OTHER ANALYTES PREVIOUSLY TESTED (I.E., CHLORIDE, CREATININE, PHOSPHORUS, SODIUM, AND TOTAL PROTEIN) YIELDED EXPECTED RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED. AFTER CONTACTING THE CUSTOMER, BCI RECEIVED A RESPONSE BACK FROM THE CUSTOMER INDICATING THAT USE ERROR WAS THE LIKELY CAUSE OF THE ERRONEOUS RESULTS DUE TO A SUSPECTED LOW SAMPLE VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1