BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 3212134 · Received July 9, 2013

    Report

    Report Number
    1061932-2013-01321
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    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

    SAMPLES WERE WHOLE BLOOD DRAWN IN 2 ML EDTA TUBES AND ANALYZED IN THE PRIMARY MODE WITHIN 60 MINUTES OF BEING DRAWN. ALL SAMPLES WERE STORED AT ROOM TEMPERATURE. PREVIOUSLY-RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. UNIT IS CURRENTLY PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY RANGE. RAW DATA FILES WERE PROVIDED BY THE CUSTOMER, BUT ANALYSIS IS STILL PENDING. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT DOCUMENTING THAT THE INTERMITTENT ERRONEOUS HEMOGLOBIN (HGB) RESULTS HAVE BEEN HAPPENING 2-3 TIMES A DAY FOR THE PAST FEW DAYS. UPON FURTHER EVALUATION, THE FSE FOUND THAT ROCKER BED RIBBON CABLE WAS HITTING THE HGB LAMP, AND THE FSE REROUTED THE CABLE. THE FSE ALSO OBSERVED THE WHITE BLOOD CELL (WBC) BATH WAS NOT DRAINING FULLY ONE TIME, AND IT GENERATED A HIGH HGB (174) READING. THE FSE REPLACED SLUGGISH ACTUATORS ON VALVES (VL 4 AND VL 6). THE FSE ALSO REPLACED CHECK VALVE ON HGB WASTE LINE. THE FSE REPLACED: CHOKES FOR 5PSI GOING TO HGB CUVETTE AND WBC BATH; HOWEVER, THE HGB CVS WAS STILL HIGH. THE FSE THEN REPLACED HGB CUVETTE AND ALL TUBING ATTACHED TO IT, AND THE HGB LAMP, THE ACTUATOR AND PINCH VALVE MOUNT FOR VL3 (CBC LYSE). THE FSE CHECKED THE REPRODUCIBILITY, AND NOW THEY WERE PASSING WITH COEFFICIENT OF VARIATIONS (%CVS) AROUND 0.3-0.4%. THE FSE RAN PATIENT SAMPLES WITH ACCEPTABLE RESULTS. THE FSE BELIEVED THE INTERMITTENT ERRONEOUS HGB READINGS WERE CAUSED BY THE STICKING VALVE (VL4) ACTUATOR. THE VL4 DRAINS THE HGB CUVETTE, AND HAVING IT STICK IN THE OPEN OR CLOSED POSITION COULD CAUSE FALSE READINGS. FAILURE MODE WAS LIKELY ATTRIBUTED TO THE SLUGGISH ACTUATORS ON VL4.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THEY OBTAINED ERRONEOUS HEMOGLOBIN (HGB) RESULTS ON THE COULTER LH 750 ANALYZER. THE CUSTOMER INDICATED THAT THE ERRONEOUS HGB RESULTS OCCURRED ON FIVE (5) PATIENT SAMPLES ON TWO (2) DIFFERENT DAYS. PER CUSTOMER, THE SAMPLES WERE RUN ON ANOTHER INSTRUMENT IN THE CUSTOMER'S LABORATORY AND RESULTS RECOVERED WERE NORMAL. THE CUSTOMER ALSO RERAN THOSE SAMPLES ON THE ORIGINAL LH750 INSTRUMENT AND HGB RESULT FOR PATIENT 4 MATCHED THE OTHER INSTRUMENT HGB RESULT. THE HGB ERRONEOUS RESULTS WERE CAUSING GENERATION OF THE ERRONEOUS MEAN CORPUSCULAR HEMOGLOBIN (MCH) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) VALUES SINCE HGB IS USED TO CALCULATE THOSE PARAMETERS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY, OR CHANGED TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. THIS REPORT IS TO COVER PATIENT RESULTS ANALYZED ON (B)(6) 2013. MDR-1061932-2013-1320 IS BEING SUBMITTED TO REPORT RESULTS OBTAINED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312223 COULTER® LH 750 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR