BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1800 ANALYZER

    MDR report key: 956823 · Received November 30, 2007

    Report

    Report Number
    2919069-2007-00235
    Event Type
    Other
    Date Received
    November 30, 2007
    Date of Event
    September 12, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (INVESTIGATION IS PENDING). 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 ACCOUNT STATED THEY GENERATED A HIGH WBC RESULT WITH NO RESISTANT RBC FLAG ON A PT SPECIMEN WHEN PROCESSING ON THE CD SAPPHIRE. INITIALLY, THE SPECIMEN TESTED WBC=253, 000 (NO UNITS OF MEASUREMENT GIVEN) AND A RESISTANT RBC FLAG. THE SPECIMEN WAS REPEATED IN CBC R MODEL GENERATING WBC=30,700 AND 31,000 AND 28,800 WITH NO RESISTANT RBC FLAG. THE PATIENT WAS MEASURED ON THE CD3700 WITH WIC=8,960/WOC=13,400 AND A RESISTANT RBC FLAG. THE PT TESTED DC1800 WBC=9,300. THE CD SAPPHIRE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR