BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2210134 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01061
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 15, 2010
    Report Date
    February 25, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QC SPECS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN ONCE A DAY IN THE MORNING, WERE RUN BEFORE AND AFTER THE SAMPLE RUN, AND RECOVERED IN RANGE. FIELD SERVICE WAS NOT DISPATCHED TO EVALUATE THE ANALYZER. TWO CUSTOMER CONTACTS PROVIDED INFO AND IT WAS NOT CLEAR IF THE BOTH SAMPLES WERE FROM THE SAME PT OR IF THE CUSTOMER HAD MISIDENTIFIED THE SAMPLE. IF THE SAMPLES WERE FROM THE SAME PT, COMPARISON OF THE DIFFERENCES IN THE RESULTS FROM THE 2 SAMPLES INDICATE THE (B)(6) 2010 SAMPLE DISPLAYS A TYPICAL PATTERN OF INADEQUATE MIXING. IF THE CUSTOMER HAD MISIDENTIFIED ONE OF THESE SAMPLES, THE ISSUE WAS OPERATOR ERROR. PRODUCT LABELING STATES: WHEN WBC AND PLATELET COUNTS ARE TOO HIGH OR LOW, AND HGB AND RBC COUNT ARE OPPOSITE, TOO LOW OR TOO HIGH, THE SAMPLE WAS NOT MIXED ADEQUATELY BEFORE ASPIRATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH RED BLOOD CELL (RBC) COUNT AND HEMOGLOBIN (HGB) RESULTS WERE OBTAINED ON (B)(6) 2010 WHEN USING A COULTER AC-T DIFF 2 ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN ANOTHER SAMPLE WAS OBTAINED FROM THE SAME PT ON (B)(6) 2010. THE TEST RESULTS WERE LOWER FOR RBC COUNT AND HGB, AND HIGHER FOR WHITE BLOOD CELL (WBC) COUNT AND PLATELET COUNT. THE CUSTOMER DETERMINED THAT THE TEST RESULTS OBTAINED WITH THE SAMPLE DRAWN ON (B)(6) 2010 WERE CORRECT, BASED ON HISTORICAL TEST RESULTS FROM THE PT. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK