BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3122412 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00886
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE WBC ISSUES. THE FSE BLEACHED THE WBC APERTURE BATH, REPLACED THE LYSE PUMP, DILUENT PUMP AND LYSE CHECK VALVE, AND ALL WASTE TUBING. UPON FURTHER INVESTIGATION THE FSE FOUND THE MAIN WASTE SMASHED AGAINST THE POWER CONDITIONER. PER ADDITIONAL COMMUNICATION WITH THE FSE ON (B)(6) 2013, THE INSTRUMENT WAS EXPERIENCING DIFFERENTIAL VOTE-OUTS (NUMERIC VALUES), AND SPIKES ON THE WBC HISTOGRAMS AND SOME AFFECT TO PLT VALUES. LATEX CALIBRATION WAS BELOW THE USUAL RANGE OF 38 VALUE. THE FSE DETERMINED THAT THE ISSUE WAS RELATED TO THE ACT DIFF 2 ANALYZER MAIN BOARD WHICH WAS REPLACED. THE MAIN BOARD HAS BEEN REQUESTED FOR RETURN TO BEC FOR FURTHER EVALUATION. AS OF (B)(4) 2013, AFTER SERVICE, THE CUSTOMER INDICATED THAT THERE HAVE BEEN NO FURTHER ISSUES. FAILURE MODE WAS THE ACT DIFF 2 MAIN BOARD WHICH WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) HAVING ONGOING WHITE BLOOD COUNT (WBC) ISSUES ON THE COULTER ACT DIFF 2 ANALYZER. THE INSTRUMENT WAS EXPERIENCING DIFFERENTIAL REGION FLAGS ON THE CONTROLS. CONTROLS NEEDED TO BE RUN SEVERAL TIMES BEFORE THE RESULTS WERE WITHIN RANGE, ESPECIALLY THE HIGH CONTROL. REPLACEMENT CONTROLS WERE SENT TO THE CUSTOMER DURING THIS PERIOD, BUT DID NOT RESOLVE THE ISSUE. PLATELET (PLT) WAS ALSO FAILING ON A STARTUP. THE CUSTOMER INDICATED THAT ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. MANUAL SMEARS WERE PERFORMED FOR RESULTS AFFECTED. INSTRUMENT PRINTOUTS, CONTROLS, PROFICIENCY DATA WERE REQUESTED, BUT NOT PROVIDED FOR THE INVESTIGATION. PER CONVERSATION WITH THE CUSTOMER ON (B)(6) 2013, THE CUSTOMER IS NOT AWARE OF ANY REPORTS OF DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224521 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC *T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1