BEUDAMED
    FDA Adverse Event Other Summary report: N

    FP1000 CELL PREPARATION SYSTEM

    MDR report key: 826311 · Received February 20, 2007

    Report

    Report Number
    1061932-2007-00005
    Event Type
    Other
    Date Received
    February 20, 2007
    Date of Event
    January 29, 2007
    Report Date
    February 20, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS CONFIRMED THAT THIS ISSUE AFFECTS BOTH VERSIONS: 1.1 AND 1.2 SOFTWARE. THIS PROBLEM COULD RESULT IN ERRONEOUS YET CREDIBLE RESULTS TO BE GENERATED AND IF PIVOTAL ASSAYS (EG. LEUKOSURE OR STEM KITS, OR CD34+) ARE TESTED TREATMENT COULD BE AFFECTED. THE SOURCE OF THE ERRORS WAS THE LACK OF VENTING FOR ALL TUBES. HOWEVER, THE ROOT CAUSE IS UNK AT THIS TIME AND THE PROBLEM IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN INTERNAL TESTING (IN-HOUSE TESTING), PRODUCT DEVELOPMENT GROUP DISCOVERED FOLLOWING ISSUES ON THE FP1000 CELL PREPARATION SYSTEM: THE SAMPLE VOLUMES DISPENSED BY THE FP1000 CELL PREPARATION SYSTEM ARE LOWER THAN EXPECTED UNDER THE FOLLOWING CONDITIONS: IF SPECIMEN TUBES ARE OPENED AND RECAPPED IN THE BATCH MODE. WHEN THERE IS AN EXCESSIVE VACUUM IN SPECIMEN TUBES THAT HAVE BEEN UNDER FILLED DURING THE SPECIMEN COLLECTION. PT SAMPLES WERE NOT BEING USED DURING THIS INTERNAL TEST AND NO ERRONEOUS RESULTS WERE PRODUCED. NO EFFECT TO PT TREATMENT HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FP1000 CELL PREPARATION SYSTEM PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE JQW BECKMAN COULTER, INC. FP1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA