BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 8/10 ANALYZER

    MDR report key: 2927559 · Received January 23, 2013

    Report

    Report Number
    1061932-2013-00037
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE WITHIN LIMITS AT THE TIME OF THE EVENT AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. SAMPLE COLLECTION DETAILS WERE NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND NO INSTRUMENT PROBLEMS. CONTROLS RECOVERED WITHIN THE MEAN AND REPRODUCIBILITY WAS WITHIN SPECIFICATIONS. FSE NOTED THE TECHNOLOGY DIFFERENCES BETWEEN INSTRUMENTS AND STATED THAT THE RESULT OF 7.3G/DL ON THE ACT8/10 INSTRUMENT AND THE 8.0G/DL ON THE REFERENCE INSTRUMENT WERE BOTH BELOW THE PATIENT LOW LIMIT. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT ONE PATIENT SAMPLE RUN ON THEIR COULTER ACT 8/10 ANALYZER GAVE A HGB RESULT OF 7.3G/DL WITHOUT AN INSTRUMENT FLAG; THE PATIENT WAS SENT TO THE HOSPITAL AND REDRAWN WHERE THE HGB WAS 8.0G/DL AND WAS CONSIDERED CORRECT. BEC REVIEW OF THE CUSTOMER SUPPLIED DATA SHOWED THAT THE INSTRUMENT GAVE HIGHER PLATELET (PLT) RESULTS COMPARED TO THE REFERENCE INSTRUMENT. HOWEVER, THE INSTRUMENT GAVE AN INSTRUMENT GENERATED FLAG ON PLT TO ALERT THE OPERATOR TO FURTHER REVIEW THE SAMPLE RESULTS. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, JUST REDRAWN AND RUN ON A REFERENCE INSTRUMENT. THERE WAS NO IMPACT OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32694 COULTER® ACT 8/10 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT 8/10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1