BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2984193 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00319
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMATOCRIT (HCT), MEAN CELL VOLUME (MCV), MEAN CELL HEMOGLOBIN (MCH), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) AND ELEVATED RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) RESULTS, FOR ONE PATIENT, INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER STATED HEMOGLOBIN AND HEMATOCRIT (H&H) CHECK FAILURES WERE GENERATED. SUBSEQUENT ANALYSIS OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, RECOVERED NORMAL RESULTS. THE ERRONEOUS RESULTS (AUTO VERIFIED) WERE RELEASED OUT OF THE LABORATORY. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CONTROLS ARE PERFORMED ONCE EVERY 24 HOURS AND WERE WITHIN SPECIFICATION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86613 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR