BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD3200SL 110

    MDR report key: 1000892 · Received February 21, 2008

    Report

    Report Number
    2919069-2008-00390
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISON/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED DISCREPANT RESULTS BETWEEN THE OPEN AND CLOSED MODES OF OPERATION ON THE CELL-DYN 32000 SL 110-REFURBISHED ANALYZER. THE CUSTOMER GAVE THE FOLLOWING EXAMPLE: WBC, OPEN MODE: 6.14, CLOSED MODE: 0.46/0.23 K/UL. HGB, OPEN MODE: 15.7, CLOSED MODE: 16.3/9.8 G/DL. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER STATES THAT THE DIFFERENTIAL RESULTS DO NOT MATCH BUT ALL OTHER PARAMETERS CORRELATE. THE CUSTOMER DID NOTE THAT BLOOD WAS VISIBLE IN THE TUBING FROM THE CLOSED MODE NEEDLE TO THE Y-VALVE. A NUMBER OF TROUBLESHOOTING PROCEDURES DID NOT RESOLVE THE ISSUE AND A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200SL 110 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISON/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK