BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4233349 · Received November 6, 2014

    Report

    Report Number
    1061932-2014-02772
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED POOR CONNECTION AT THE LS PREAMP AND LS SENSOR. THE FSE REPLACED THE LS PREAMP AND LS SENSOR TO RESOLVE THE REPORTED ISSUE. THE FSE COMPLETED ALIGNMENT TO SPECIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW DIFF AND RETIC LATRON LIGHT SCATTER INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER STATED PATIENT RESULTS WERE NOT IMPACTED - NO ERRONEOUS RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713386 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1