BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1903790 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01235
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO EACH EVENT, TPM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE ESTABLISHED RANGES. INTERMITTENTLY LOW TPM FLIERS WERE GENERATED BY THE ANALYZER AND SOME ERRONEOUS RESULTS WERE REPORTED. ON (B)(4) 2010, A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING ON THE TOTAL PROTEIN MODULE FOR FAILED CALIBRATIONS. THE CUSTOMER REQUESTED A NEW MODULE AND WAS PLACED ON THE ANALYZER. ON (B)(6) 2010, THE CUSTOMER CALLED BCI HOTLINE FOR LOW TPM FLYERS. ON (B)(4) 2010, THE FSE REPLACED THE SAMPLE PROBE. AS OF (B)(4) 2010, TPM WAS OPERATING WITHIN THE SPECIFICATIONS. THE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TOTAL PROTEIN (TPM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED HIGHER RESULTS. AMENDED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT THE PHYSICIAN DID NOT BELIEVE THE RESULTS AND NO PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1