BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 3232807 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01470
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 INSPECTED THE INSTRUMENT AND CONFIRMED THAT WHITE BLOOD CELL (WBC) APERTURE #1 AND APERTURE # 3 WERE 'NOISY', AND NOT MATCHING APERTURE #2, THUS CAUSING INCORRECT ELEVATED WBC COUNTS. THE WBC BATH WAS REPLACED, AND ALL THREE APERTURES NOW MATCHING. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. FAILURE MODE WAS ATTRIBUTED TO THE WBC BATH WHICH NEEDED REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT WHITE BLOOD COUNT (WBC) RESULTS OBTAINED ON TWO (2) DIFFERENT PATIENT SAMPLES RUN ON COULTER LH 750 ANALYZER (LH750-1) DID NOT MATCH THE WBC RESULTS RECOVERED ON RERUN ON ANOTHER LH750 ANALYZER (LH750-2) WHICH WERE CONSIDERED AS CORRECT. PATIENT DATA PROVIDED FOR REVIEW INDICATED THAT THE TWO PATIENT SAMPLES INITIALLY RUN ON LH750-1 RECOVERED HIGHER WBC RESULTS WITHOUT INSTRUMENT GENERATED MESSAGES, COMPARED TO THE RESULTS OBTAINED FROM THE LH750-2 ANALYZER WHICH WERE REPORTED OUT OF THE LABORATORY AS CORRECT. THE SAMPLES WERE RERUN ON THE LH750-2 INSTRUMENT FOR CONFIRMATION, DUE TO THE RESULTS FAILED THE PATIENT¿S DELTA CHECK WHEN RUN ON THE ORIGINAL INSTRUMENT (LH750-1). CONTROL DATA ON THE DAY OF THE EVENT REVEALED THAT THE NORMAL CONTROL WAS HIGH OUT OF RANGE FOR WBC AND THE OTHER TWO LEVELS OF CONTROLS RECOVERED WITHIN RANGE, THEREFORE, THE CUSTOMER CONTINUED TO PROCESS PATIENT SAMPLES PER LABORATORY PROTOCOL, SINCE TWO OUT OF THREE CONTROLS WERE IN RANGE. 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
    334268 COULTER® LH 750 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1