BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3223240 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01390
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED BUT COULD NOT CONFIRM AN ACTIVE LEAK FROM THE MANUAL PROBE. HOWEVER, THE FSE DID FIND A SLIGHT LEAK IN THE DIAPHRAGM OF THE WBC (WHITE BLOOD CELL) DILUENT DISPENSER WHICH WAS UNRELATED TO THE LEAK FROM THE MANUAL PROBE. THE FSE REPLACED THE WBC DILUENT DISPENSER TO RESOLVE THE ISSUE. RESULTS: THE FSE COULD NOT CONFIRM AN ACTIVE LEAK FROM THE MANUAL PROBE AS INITIALLY REPORTED BY THE CUSTOMER. HOWEVER, FAILURE MODE OF THE LEAK IN THE DIAPHRAGM OF THE WBC DISPENSER IS ATTRIBUTED TO A DEFECTIVE WBC DILUENT DISPENSER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 ML OF BLOOD LEAKED FROM THE MANUAL PROBE OF THE LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND BLOOD LEAKED ONTO THE COUNTER. THE CUSTOMER STATED THAT TWO PATIENTS RECOVERED WITH ERRONEOUS AND ERRATIC RESULTS FOR ALL CBC (COMPLETE BLOOD COUNT) PARAMETERS WHILE USING THE MANUAL PROBE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES, AND EYEWEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. THE CUSTOMER STATED THAT THE OPERATOR DID NOT RUN CONTROLS FOLLOWING THE BLOOD LEAK FROM THE MANUAL PROBE; THE OPERATOR IMMEDIATELY RAN TWO PATIENT SAMPLES USING THE MANUAL MODE FOLLOWING THE LEAK. DATA FROM INSTRUMENT PRINTOUTS REVEALED THAT ALL CBC PARAMETERS RECOVERED ERRONEOUSLY LOW RESULTS FOR THE FIRST PATIENT EXCEPT FOR RBC (RED BLOOD CELL), HCT (HEMATOCRIT), AND MCV (MEAN CORPUSCULAR VOLUME) WHICH RECOVERED ERRONEOUSLY HIGH RESULTS WITH SUSPECT MESSAGES AS COMPARED TO THE RERUN RESULTS IN AUTO MODE ON THE ORIGINAL INSTRUMENT. THE RERUN RESULTS IN AUTO MODE WAS CONSIDERED CORRECT BY THE CUSTOMER. THE DIFFERENTIAL RESULTS CORRELATED BETWEEN THE ORIGINAL RUN IN THE MANUAL MODE AND THE RERUN IN THE AUTO MODE FOR THIS PATIENT. DATA FROM INSTRUMENT PRINTOUTS REVEALED THAT ALL CBC RESULTS RECOVERED ERRONEOUSLY LOW FOR THE SECOND PATIENT WITH SUSPECT MESSAGES. THE MCV AND RDW (RED BLOOD CELL DISTRIBUTION WIDTH) VOTED OUT (¿¿) AND THE MCHC (MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION) WAS OVER RANGE (++++). THE SAMPLE WAS REPEATED FOR HGB (HEMOGLOBIN) AND HCT ONLY, ON DIFFERENT INSTRUMENTATION, AND THE RESULTS WERE CONSIDERED CORRECT BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324554 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1