BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T SERIES ANALYZER

    MDR report key: 2944669 · Received February 5, 2013

    Report

    Report Number
    1061932-2013-00132
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MEAN CORPUSCULAR VOLUME (MDV) CALIBRATION FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS HEMOGLOBIN AND HEMATOCRIT (H&H RESULTS) FOR 5 PATIENTS INVOLVING A COULTER ACT SERIES ANALYZER OVER A PERIOD OF TWO DAYS. THIS REPORT IS FOR THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE SEE MEDWATCH #1061932-2013-00133 FOR THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER REPORTED OBTAINING ERRONEOUS RESULTS FOR ONE PATIENT ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND INCORRECT RESULTS WERE OBTAINED ONCE MORE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT. THE CUSTOMER INDICATED THAT THE SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER AT A REFERENCE LABORATORY AND RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER HAD STOPPED USING THE ANALYZER FOLLOWING THE EVENT UNTIL INSTRUMENT WAS SERVICED. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND DETERMINED THAT THE HEMOGLOBIN (HGB) LAMP VOLTAGE COULD NOT BE ADJUSTED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE HGB LAMP WHICH HAD A LOW VOLTAGE. THE FSE THEN REVIEWED QUALITY CONTROL (QC) AND PATIENT SAMPLE RESULTS AND FOUND THE MEAN CORPUSCULAR VOLUME (MCV) NOT MATCHING THEREBY CAUSING THE HEMATOCRIT TO NOT MATCH. THE FSE PROCEEDED TO ADJUST THE MCV CALIBRATION FACTOR AND ISSUE WAS RESOLVED. THE FSE VERIFIED THE REPAIRS AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE WAS DETERMINED TO BE THE HGB LAMP ALONG WITH THE MCV CALIBRATION FACTOR WHICH NEEDED ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49279 COULTER® AC*T SERIES ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1