BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2024291 · Received March 18, 2011

    Report

    Report Number
    1061932-2011-00154
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 5ML HEMOGARD, EVACUATED TUBE, AND WERE STORED AT ROOM TEMPERATURE. QC RUN BEFORE THE EVENT RECOVERED WITHIN ACCEPTABLE LIMITS. A FIELD SERVICE ENGINEER (FSE) VERIFIED REPRODUCIBILITY IN SECONDARY MODE AND MODE TO MODE RESULTS USING PATIENT SAMPLES AND 5C CONTROLS. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THIS EVENT IS UNKNOWN AT THIS TIME. HOWEVER, CUSTOMER STATED THAT CLOTS WERE PRESENT IN PATIENT'S SPECIMEN COLLECTED ON (B)(6) 2011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY HIGH RED BLOOD COUNT (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND FALSELY LOW PLATELET (PLT) RESULTS GENERATED BY THE COULTER LH 750 ANALYZER FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED BY THE PHYSICIAN. A FRESH SAMPLE COLLECTED FROM THE PATIENT AND REPEAT OF THE ORIGINAL SAMPLE GAVE LOWER RESULTS FOR RBC, HGB, HCT, AND HIGHER RESULTS FOR PLT. SOME RESULTS WERE FLAGGED WITH LAB LIMITS WITH EITHER "H" OR "L" FLAGS. THERE WAS NO DEATH, INJURY OR EFFECT 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

    Patients

    Seq Age Sex Outcome Treatment
    1