BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3607136 · Received February 4, 2014

    Report

    Report Number
    1061932-2014-00277
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE STABILYSE (DIFFERENTIAL PRESERVATIVE) PUMP WAS INTERMITTENTLY GENERATING AIR BUBBLES LEADING TO A REDUCTION IN VOLUME OF STABILYSE DISPENSED, CAUSING THE INSTRUMENT TO GENERATE PARTIAL CLOG 2 (PC2) ERRORS. THE FSE PROCEEDED TO REPLACE THE STABILYSE (DIFFERENTIAL PRESERVATIVE) PUMP TO RESOLVE THE ISSUE WITH NO DIFFERENTIAL RESULTS. ALTHOUGH THE INSTRUMENT ALSO GENERATED "DIL SOL/OPPS +15V" ERROR AT THE TIME OF THE EVENT, THE ERROR WAS UNRELATED TO THE ISSUE REPORTED BY THE CUSTOMER; THE FSE COULD NOT CONFIRM THE ERROR AND STATED THAT THE ERROR WAS ONLY OBSERVED ONCE BY THE CUSTOMER AND HAS NOT REOCCURRED SINCE. FAILURE MODE OF THE NO DIFFERENTIAL RESULT ISSUE IS ATTRIBUTED TO A MALFUNCTIONING STABILYSE PUMP AND THE INSTRUMENT GENERATED PC2 ERRORS TO ALERT THE CUSTOMER OF THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NO DIFFERENTIAL RESULTS WHICH WERE FLAGGED WITH PARTIAL CLOG 2 (PC2) ERRORS WHILE RUNNING PATIENT SAMPLES ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE ISSUE OCCURRED INTERMITTENTLY AND WAS NOT ISOLATED TO A SINGLE PATIENT SAMPLE. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY PRINTOUTS OF RESULTS FOR REVIEW. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT GENERATED "DIL SOL/OPPS +15V" ERROR DURING THE EVENT. THE "DIL SOL/OPPS +15V" ERRORS ARE SPECIFIC TO DIRECT CURRENT (DC) POWER FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72179 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1