BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH500 ANALYZER

    MDR report key: 3211277 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01316
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ADJUSTED THE MODE TO MODE FOR HEMOGLOBIN (HGB) IN MANUAL MODE. WHILE ON SITE, THE FSE ALSO REPLACED VALVE (PV4) TO ADDRESS THE HIGH VACUUM OUT OF RANGE ERRORS REPORTED BY THE FSE WHILE TROUBLESHOOTING. THE FSE ALSO REPLACED THE ACTUATOR FOR VALVE (PV4). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ADJUSTED THE MODE TO MODE FOR HEMOGLOBIN (HGB) IN MANUAL MODE. WHILE ON SITE, THE FSE ALSO REPLACED VALVE (PV4) TO ADDRESS THE HIGH VACUUM OUT OF RANGE ERRORS REPORTED BY THE FSE WHILE TROUBLESHOOTING. THE FSE ALSO REPLACED THE ACTUATOR FOR VALVE (PV4). FAILURE MODE WAS ATTRIBUTED TO A MODE TO MODE HGB ADJUSTMENT AND TO THE ACTUATOR TO PV4 WHICH NEEDED TO BE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT LOWER HEMOGLOBIN (HGB) RESULTS WERE RECOVERED FROM COULTER LH500 INSTRUMENT IN MANUAL (SECONDARY) MODE, COMPARED TO THE RESULTS OBTAINED FROM THIS INSTRUMENT IN AUTO MODE. THE CUSTOMER ALSO REPORTED THAT ERRONEOUS HGB RESULTS WERE OBTAINED FOR A SINGLE SAMPLE RUN ON THE LH500 ANALYZER, COMPARED TO RESULTS OBTAINED ON ANOTHER LH500 ANALYZER WHICH WERE CONSIDERED CORRECT. DATA PROVIDED FOR REVIEW INDICATED THAT THE SAMPLE WAS INITIALLY RUN ON LH500-1 IN THE AUTOMATED MODE, AND IT WAS RERUN TWO ADDITIONAL TIMES FOR CONFIRMATION ON LH500-1 AND LH500-2, SINCE THE INITIAL RESULTS TRIGGERED A DELTA CHECK. LOWER COMPLETE BLOOD COUNT (CBC) PARAMETERS WITHOUT INSTRUMENT GENERATED MESSAGES WERE OBTAINED ON LH500-1 ON INITIAL RUN COMPARED TO THE RESULTS FROM LH500-2, WHICH WERE REPORTED OUT AS CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, AND THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310682 COULTER LH500 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR