BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2060469 · Received April 17, 2011

    Report

    Report Number
    1061932-2011-00265
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE SAMPLE COLLECTION AND STORAGE INFORMATION. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE REPLACED W BC DILUENT DISPENSE PUMP, SEVERAL PINCH VALVES AND ASSOCIATED TUBING. ALSO ADJUSTED RBC AND HGB CALIBRATION FACTORS AND VERIFIED INSTRUMENT OPERATION. ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE LH750 INSTRUMENT GENERATED ERRATIC WBC, RBC, HGB AND MCV RESULTS FOR THREE (3) PATIENTS WITH INSTRUMENT GENERATED DIMORPHIC REDS SUSPECT MESSAGES FOR PATIENT ONE (1) AND NO INSTRUMENT GENERATED FLAGS FOR PATIENT TWO (2) AND THREE (3). PATIENT ONE'S SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT AND RECOVERED HIGHER WBC AND LOWER HGB RESULTS, WHICH THE CUSTOMER CONSIDERS CORRECT. THE SAME SPECIMEN WAS RERUN ON THE ORIGINAL LH750 INSTRUMENT AND RECOVERED LOWER WBC AND LOWER HGB RESULTS. PATIENT TWO'S SPECIMEN WAS RERUN ON THE ORIGINAL LH750 INSTRUMENT AND RECOVERED HIGHER WBC RESULTS. HGB RESULTS WERE THE SAME. PATIENT THREE'S SPECIMEN WASRERUN ON THE ORIGINAL LH750 INSTRUMENT AND RECOVERED HIGHER WBC AND LOWER HGB RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1