BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 3112561 · Received May 14, 2013

    Report

    Report Number
    1061932-2013-00822
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CONFIRMED THAT THE INSTRUMENT WAS GENERATING HIGH HGB RESULTS. PER PHONE CONVERSATION, THE FSE STATED THAT HE REPLACED SLUGGISH ACTUATORS ON VL12C (BATH DRAINS) AND VL57A (PROBE/NEEDLE DRAIN VACUUM) TO RESOLVE THE ISSUE. THE FSE ALSO REPLACED THE HGB CUVETTE AND HGB LAMP AS PREVENTATIVE MAINTENANCE. THE INSTRUMENT WAS VERIFIED AND TESTED WITHIN SPECIFICATIONS. THE FAILURE MODE OF THE ERRONEOUS HGB AND MCHC RESULTS WAS RELATED TO SLUGGISH ACTUATORS ON VL57A (PROBE/NEEDLE DRAIN VACUUM) WHICH WAS NOT ALLOWING THE PROPER DRAINAGE OF VL12C (BATH DRAINS) RESULTING IN CARRY OVER. THIS EVENT IS ALSO A USE ERROR; NORMAL LEVEL CONTROL SAMPLES WERE RUN BUT FAILED IMMEDIATELY BEFORE THE EVENT AND AFTER PATIENT SAMPLES WERE RUN. PER LABELING, THE LH750 INSTRUCTIONS FOR USE (IFU) STATES FAILURE TO RECOVER CONTROL VALUES WITHIN THE EXPECTED RANGE IN EITHER MODE SHOULD BE INVESTIGATED BEFORE PROCEEDING WITH THE ANALYSIS OF PATIENT SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY OBTAINED ERRATIC HEMOGLOBIN (HGB) RESULTS ON TWO PATIENT SAMPLES TESTED ON THE COULTER LH 750 ANALYZER. DATA PROVIDED BY THE CUSTOMER FOR REVIEW INDICATED HEMATOCRIT/HEMOGLOBIN (H/H) CHECK FAILURES WITH LOWER HGB AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS ON THE INITIAL RUN COMPARED TO THE RESULTS OBTAINED ON THE RE-RUN WITH NO INSTRUMENT GENERATED MESSAGES. THE 5C CELL CONTROLS WERE RUN IMMEDIATELY BEFORE AND AFTER PATIENT SAMPLES A AND B WERE RUN, WHICH DEMONSTRATED HGB, MEAN CORPUSCULAR HEMOGLOBIN (MCH) AND MCHC FAILURE FOR THE NORMAL CONTROL. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT THE LABORATORY, AND THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE RE-RUNS WERE CONSIDERED CORRECT FOR BOTH PATIENT SAMPLES. PATIENTS' RESULTS ARE PROVIDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212214 COULTER® LH 750 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1