BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 8523435 · Received April 17, 2019

    Report

    Report Number
    2919069-2019-00035
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 24, 2019
    Report Date
    May 16, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740002732
    PMA / PMN Number
    K980614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SUBSEQUENT SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) RESOLVED THE ISSUE BY REPLACING THE TUBING IN THE PINCH VALVE ABOVE THE OPEN MODE PROBE (PART NUMBER 9130542). A REVIEW OF INSTRUMENT STATUS DETERMINED THAT THE RECOMMENDED PREVENTIVE MAINTENANCE HAS NOT BEEN PERFORMED ON THIS INSTRUMENT, WHICH INCLUDES REPLACEMENT OF THE TUBING AFFECTED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL FOUND LABELING TO BE ADEQUATE FOR THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS OR TRENDS ASSOCIATED WITH THIS ISSUE. BASED ON THE INVESTIGATION THERE IS NO PRODUCT DEFICIENCY IDENTIFIED FOR THE CELL-DYN 3700, SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED HEMATOCRIT (HCT) RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2019 = 23.6 / 24.5. THE CUSTOMER STATED THAT THE PATIENT WAS TRANSFUSED AS POLICY IS TO TRANSFUSE PATIENTS WITH HCTS <28. THE SAMPLE WAS REPEATED IN THE AFTERNOON AND THE HCT RESULTS WERE 30.2 / 34.3. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED DUE TO THE UNNECESSARY TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318464 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740002732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other