BEUDAMED
    FDA Adverse Event Summary report: N

    HELIOS HEMATOLOGY ANALYZER

    MDR report key: 10602 · Received December 21, 1993

    Report

    Report Number
    MW1000179
    Date Received
    December 21, 1993
    Report Date
    December 14, 1993
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Product Code
    GKZ
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR HAS HAD NUMEROUS PROBLEMS WITH RELIABILITY AND PERFORMANCE OF THE INSTRUMENT SINCE DAY ONE IN FEB/MARCH OF 1993. REINSTALLATION OCCURRED IN 7/93SECOND INSTALLATION IS BETTER BUT STILL MANY VOIDOUTS OF WBC COUNTS, PET COUNTS, BACK LIT RESULTS, INCONSISTANT QC DATA (OR VERY UNSTABLE) BUT NOT SURE DUE TO INSTABILITY OF EQUIPMENT FUNCTION. THERE ARE VARIATIONS OCCURRING BETWEEN AUTO SAMPLE AND UNUSUAL SAMPLE-MODES. AUTO SAMPLER OFTEN NOT PERFORMING WELL, IF AT ALL HAS A PREPONDERANCE TO OFTEN PLUG UP. IT REQUIRES CONSTANT BLEACHING, NOT AT ALL THE PERFORMANCE THAT WAS SOLD TO RPTR. CO HAS ARGUED THAT THE PROBLEM IS RPTR'S, IT SEEMS THAT IT IS ALWAYS SOMETHING, RPTR IS OR IS NOT DOING INCLUDING THE ELECTRICAL. RPTR IS NOT NON COMPLIANT WITHOUT THEIR RECOMENDATIONS AND INSTRUCTIONS. THE INSTRUMENT IS OPERATING BELOW THE EXPECTED AND ANTICIPATED SSTANDARDS RPTR REQUIRE. RPTR HAVE DOCUMENTATION FROM AN ELECTRICAL ENGINEER THAT THE ELECTRICAL SPECS ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS HEMATOLOGY ANALYZER GKZ ROCHE DIAGNOSTIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *