BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3255371 · Received July 30, 2013

    Report

    Report Number
    2050012-2013-00532
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DKH
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS RUN PRIOR TO AND AFTER THE EVENT AND WAS WITHIN LABORATORY ESTABLISHED RANGES. THE SAMPLE WAS COLLECTED IN A PLASMA SEPARATOR TUBE AND CENTRIFUGED FOR ONLY 4 MINUTES AT 6000 RPM. THE CUSTOMER INDICATED NO ISSUES WITH THE INSTRUMENT. THE CUSTOMER STATED THAT THE LOW RESULT IS CONSISTENT WITH A SHORT SAMPLE AND THIS EVENT WAS ISOLATED TO ONE (1) PATIENT SAMPLE. THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. NO EVIDENCE OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED A FALSE LOW PHENYTOIN (PHY) RESULT FOR ONE (1) PATIENT SAMPLE OF < 0.1 UG/ML. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. DUE TO THE FALSE LOW PHY RESULT, THE PHYSICIAN ADMINISTERED ADDITIONAL PHY TO THE PATIENT. THE PHYSICIAN LATER QUESTIONED THE RESULT AND THE LABORATORY FACILITY RERAN THE ORIGINAL SAMPLE BOTH ON THE ORIGINAL DXC AND AN ALTERNATE DXC INSTRUMENT. THE REPEATED RESULTS YIELDED VALUES OF 23.4 UG/ML AND 23.3 UG/ML, RESPECTIVELY. THE CUSTOMER CONFIRMED THAT ONLY THE PATIENT'S PHY RESULT WAS ERRONEOUS. NO OTHER ANALYTES WERE QUESTIONED. NO ADDITIONAL INFORMATION REGARDING IMPACT ON PATIENT AND/OR PATIENT TREATMENT HAS BEEN PROVIDED, BY THE CUSTOMER, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354351 UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DKH BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other