BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 2260802 · Received September 22, 2011

    Report

    Report Number
    1061932-2011-01523
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LAVENDER TOPPED TUBE. CONTROLS WERE RUN BEFORE AND AFTER THE REPORTED INCIDENT AND WERE WITHIN RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE FOUND NO INSTRUMENT PROBLEMS. THE FSE VERIFIED THAT THE INSTRUMENT WAS FULLY OPERATIONAL AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. SYSTEM WAS VALIDATED. BASED ON INFORMATION PROVIDED, THE ROOT CAUSE OF EVENT CANNOT BE DETERMINED, BUT INITIAL PATIENT RESULTS ARE INDICATIVE OF INADEQUATE SAMPLE MIXING. PER PRODUCT LABELING, WHEN WBC AND PLT ARE TOO HIGH OR LOW, HGB AND RBC ARE OPPOSITE, TOO LOW OR HIGH. PROBABLE CAUSE: SAMPLE WAS NOT MIXED ADEQUATELY BEFORE ASPIRATION. SUGGESTED ACTION: REMIX SAMPLE AND CYCLE AGAIN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER AC-T DIFF 2 ANALYZER GENERATED ABNORMALLY LOW WHITE CELL COUNT (WBC) AND ABNORMALLY HIGH HEMOGLOBIN (HGB) RESULTS FOR ONE (1) PATIENT. REVIEW OF THE DATA ALSO SHOWS LOW PLATELET (PLT) AND HIGH RED CELL COUNT (RBC) AND HEMATOCRIT (HCT) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. A DOCTOR QUESTIONED THE RESULTS AND SENT THE PATIENT SAMPLE TO A REFERENCE LAB FOR REPEAT ANALYSIS. THESE RESULTS WERE CONSIDERED CORRECT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1