BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4419743 · Received January 14, 2015

    Report

    Report Number
    1061932-2015-00078
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING SPECIFIC PATIENTS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND THE HEMOGLOBIN CHAMBER WITH WHITE BUILDUP INSIDE THE CHAMBER. HE REPLACED CHAMBER TO CORRECT THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOGLOBIN BLANK SHIFT ERRORS WERE GENERATED WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER RESOLVED THE HEMOGLOBIN BLANK SHIFT ERRORS WITH TROUBLESHOOTING. AFTER RESOLUTION OF THE HEMOGLOBIN BLANK SHIFT ERRORS, THE CUSTOMER IDENTIFIED A SHIFT OF 0.6 G/DL IN THE HEMOGLOBIN TEST RESULTS FOR PATIENT SAMPLES AND A LOWER MCHC (MEAN CELL HEMOGLOBIN CONCENTRATION). THE PATIENT SPECIMENS WERE RERUN WHEN H&H (HEMOGLOBIN & HEMATOCRIT) FLAGS WERE TRIGGERED. (THE H & H FLAG IS AN OPERATOR DEFINED FLAG INDICATING THE HEMOGLOBIN AND HEMATOCRIT RESULTS DO NOT MATCH AND FURTHER REVIEW/ACTION IS REQUIRED.) THE ERRONEOUS HEMOGLOBIN TEST RESULTS WERE REPORTED OUT OF THE LABORATORY, HOWEVER, THERE WAS NO AFFECT ON PATIENT TREATMENT. QUALITY CONTROL SAMPLES RAN BEFORE THE EVENT WERE ACCEPTABLE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32182 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1