BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 2 DIFF ANALYZER

    MDR report key: 2242658 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01402
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS AND CONTROLS WERE RUN BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE PERFORMED A DECONTAMINATION SERVICE PROCEDURE AND REPLACED THE DILUENT FILTERS. PLATELET BACKGROUNDS WERE IN SPECIFICATION. NO PROBLEMS WERE OBSERVED AND THE FSE VALIDATED THE SYSTEM. ROOT CAUSE FOR THE INITIAL LOW WBC AND PLT RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT DIFF 2 ANALYZER GENERATED A FALSELY LOW PLATELET (PLT) RESULT FOR ONE (1) PATIENT SAMPLE. REVIEW OF THE LABORATORY INFORMATION SYSTEM (LIS) PRINTOUT ALSO SHOWS A LOW WHITE BLOOD COUNT (WBC) RESULT FOR THIS PATIENT. INSTRUMENT FLAGGING COULD NOT BE DETERMINED SINCE ONLY LIS PRINTOUTS WERE PROVIDED FOR THIS EVENT. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. DUE TO A CRITICAL LOW MESSAGE ON THE LIS PRINTOUT FOR THE PLATELET RESULT, THE PATIENT WAS SENT TO ANOTHER LAB AND REDRAWN. RESULTS OF THIS SAMPLE WERE CONSIDERED CORRECT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT NO OTHER PATIENTS HAD CRITICAL LOW RESULTS AND THAT THE PART-TIME WEEKEND TECHNICIAN SHOULD HAVE RE-MIXED AND RERUN THE SAMPLE PRIOR TO RELEASING THE RESULTS OUT OF THE LABORATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR