BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2132519 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00664
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT IS CURRENTLY PERFORMING WITH QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. QC WAS DONE BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) REPLACED VC37 AND THE ISSUE WAS RESOLVED. THE ROOT CAUSE IS ATTRIBUTED TO VACUUM CHAMBER 37 LEAKING AIR AND NOT SUPPLYING PRESSURE TO THE BACKWASH TANK, WHICH IN TURN SUPPLIES DILUENT TO THE HGB CUVETTE FOR THE BLANK READING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE ERRONEOUS HEMOGLOBIN (HGB) RESULTS WERE GENERATED BY THE COULTER LH 750 ANALYZER FOR THREE PATIENTS WITH NO INSTRUMENT GENERATED FLAGS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB, AND WERE ONLY DETECTED AFTER FAILING BACKGROUND CHECKS AND CONTROLS FAILING QC AT THE START OF ANOTHER SHIFT. THE SAMPLES WERE RE-TESTED ON ANOTHER INSTRUMENT AND THE RESULTS OBTAINED WERE THE CORRECT RESULTS AND WERE REPORTED OUT OF THE LAB. THE CUSTOMER CONFIRMED THAT THERE WAS NO DEATH OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1