BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3833896 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01192
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DETERMINED THE STABILISE PUMP SHOULD BE REPLACED. HE REPLACED THE PUMP, RESOLVING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WERE GENERATED FOR A SINGLE PATIENT SAMPLE WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE ERRONEOUS DIFFERENTIAL RESULTS DID NOT HAVE AN INSTRUMENT GENERATED FLAG FOR THE PRESENCE OF BLAST (IMMATURE) CELLS. THE ERRONEOUS TEST RESULTS, AND LACK OF AN INSTRUMENT GENERATED FLAG, WERE COMPARED TO TEST RESULTS AND FLAGGING OBTAINED WHEN THE PATIENT'S SAMPLE WAS RETESTED ON TWO ADDITIONAL UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS. THESE RETEST RESULTS WERE DETERMINED TO BE CORRECT. THE ERRONEOUS DIFFERENTIAL TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE LABORATORY PERFORMED A MANUAL DIFFERENTIAL AND REPORTED THOSE RESULTS. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311550 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1