BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 3243659 · Received July 23, 2013

    Report

    Report Number
    1061932-2013-01480
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE INCIDENT AND WERE WITHIN SPECIFICATIONS. CONTROLS WERE NOT RUN AFTER THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THERE WAS NO MALFUNCTION IDENTIFIED FOR THIS INSTRUMENT, BUT THE FSE PERFORMED A PREVENTIVE MAINTENANCE A (PM A) AND REPLACED PILOT ACTUATORS FOR VALVES (VL57A), (VL4), AND (VL6) TO ADDRESS THE INTERMITTENT ISSUE THAT THE CUSTOMER WAS REPORTED EXPERIENCING WITH THE HEMATOCRIT/HEMOGLOBIN (H AND H) FLAGGING. THE FSE VERIFIED THE INSTRUMENT AND COMPLETED A MODE TO MODE TEST BETWEEN THE TWO ANALYZERS USING RANDOM PATIENT SAMPLES WITH ACCEPTABLE RESULTS. FAILURE MODE WAS ATTRIBUTED TO NEEDED PREVENTIVE MAINTENANCE (PM) FOR THE INSTRUMENT.

    Description of Event or Problem · 1

    LH750 ANALYZER, SERIAL NUMBER (B)(4): THE CUSTOMER INDICATED THAT THEIR BACK-UP LH 750 INSTRUMENT (SN (B)(4)) WAS EXPERIENCING THE SAME INTERMITTENT ISSUE AS DESCIRBED BELOW FOR THE OTHER LH 750 ANALYZER. HOWEVER, NO SPECIFIC INFORMATION OR PATIENT RESULTS WERE PROVIDED IN RESPECT TO THIS EVENT. LH750 ANALYZER, SERIAL NUMBER (B)(4): THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE HEMOGLOBIN (HGB) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS WERE RECOVERING LOW ON THE COULTER LH 750 ANALYZER ON OVER 100 PATIENT SAMPLES FROM THE DAY¿S RUN. INSTRUMENT PRINTOUTS DEMONSTRATING THIS ISSUE WERE REQUESTED FROM THE CUSTOMER, BUT WERE NOT PROVIDED. AT THIS POINT, THE INSTRUMENT FLAGGING IS UNKNOWN. THE CUSTOMER STATED THE LOW RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT, AS THE CUSTOMER REPORTING THE ISSUE WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION. THIS MDR IS TO REPORT THE EVENT OCCURRED ON THE LH 750 ANALYZER, SERIAL NUMBER (B)(4). AN MDR 1061932-2013-01479 IS BEING SUBMITTED TO REPORT THE EVENT INVOLVING THE LH 750 ANALYZER, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343899 COULTER® LH 750 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1