BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2874027 · Received December 14, 2012

    Report

    Report Number
    2919069-2012-00083
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER DATA PROVIDED SHOWED THE SAMPLE POSSIBLY CONTAINS PLT CLUMPS, LYSE-RESISTANT RBCS, FRAGILE WBCS, AND NRBCS. THESE INTERFERING SUBSTANCE AND CONDITIONS ARE IDENTIFIED IN THE PRODUCT LABELING AS POTENTIAL INTERFERENTS WHICH COULD AFFECT WBC AND WBC DIFFERENTIAL RESULTS. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE CELL-DYN SAPPHIRE ANALYZER, LIST NUMBER 08H00-01, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC COUNTS FOR ONE PATIENT WHILE USING THE CELL-DYN SAPPHIRE ANALYZER COMPARED TO OTHER RESULTS GENERATED ON DIFFERENT ANALYZERS. THIS PATIENT HAD PREVIOUSLY UNDERGONE TRANSPLANTATION AND CHEMOTHERAPY, THE CUSTOMER INDICATED THE FOLLOWING RESULTS: (B)(6) 2012: CELL-DYN SAPPHIRE: 2.25 10E9/L, XE 5000 (SYSMEX): 0.02 10E9/L, CELL-DYN 3700: 0.027 G/L, CELL-DYN SAPPHIRE: RUN WITH RESISTANT RBC: 0.168 10E9/L, CELL-DYN 3700: RUN WITH RESISTANT RBC: 0.18 G/L; (B)(6) 2012: CELL-DYN SAPPHIRE: 4.82 10E9/L, CELL-DYN SAPPHIRE: RUN WITH RESISTANT RBC: 3.98 10E9/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED DUE TO THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR