BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 10

    MDR report key: 1011826 · Received March 11, 2008

    Report

    Report Number
    1061932-2008-00012
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED, VIA VENIPUNCTURE, IN A 3ML BD TUBE, AND WAS STORED AT ROOM TEMPERATURE. THE ERRONEOUS RESULTS OCCURRED IN A WHOLE BLOOD MODE OF OPERATION FOR A SPECIFIC SAMPLE. THE INSTRUMENT IS WORKING WITHIN QC SPECS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REPLACED RBC COUNT VALVE, SWEEP FLOW, AND TRIPLE SYRINGE. THE FSE VERIFIED THE INSTRUMENT. AS OF 02/25/08, THERE HAVE BEEN NO FURTHER ISSUES OF LOW RESULT RECOVERY FROM THIS ACCOUNT. HARDWARE ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT PLATELET (PLT) RESULTS GENERATED BY THE COULTER ACT 10 ANALYZER DID NOT CORRELATE WITH A REFERENCE LAB RESULT FOR THE SAME SAMPLE. THE INITIAL PLT RESULT WAS 108X10 TO THE THIRD POWER CELLS/UL. THE SAMPLE WAS RETESTED AND REPEATED RESULT WAS 126X10 TO THE THIRD POWER CELLS/UL. THE SAMPLE WAS TESTED AT A REFERENCE LAB AND PLT RESULT OF 225X10 TO THE THIRD POWER CELLS/UL WAS OBTAINED. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFORMATION, THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT 10 AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA