BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK INFORM II SYSTEM

    MDR report key: 6259685 · Received January 18, 2017

    Report

    Report Number
    6259685
    Event Type
    Death
    Date Received
    January 18, 2017
    Date of Event
    January 17, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS OPERATIONS, INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS PART OF THE PATIENT'S STANDARD GLUCOSE MONITORING PROTOCOL, AN EVENING FINGER STICK WAS PERFORMED USING POINT OF CARE TESTING VIA THE ACCU-CHEK INFORM II GLUCOSE METER. THE INITIAL RESULTS DISPLAYED A READING OF "RRLO WITH A MESSAGE W-510 OUT OF REPORTABLE RANGE, VERIFIED WITH VENOUS COLLECTION. REPEAT TESTS WERE DONE USING OTHER ACCU-CHEK INFORM II GLUCOMETERS THAT DISPLAYED THE SAME RESULTS. STAFF INTERPRETED THE ERROR MESSAGES DISPLAYED AS THE ACTUAL GLUCOSE READING AND REPORTED THESE RESULTS TO MEDICAL STAFF. THIS MISINTERPRETATION OF THE BLOOD GLUCOSE LEVEL BEING 510 RESULTED IN THE PATIENT RECEIVING ADDITIONAL INSULIN COVERAGE. A REVIEW OF THE CASE AND BLOOD GLUCOSE MANAGEMENT WAS UNDERTAKEN AND IT WAS DETERMINED THAT THE DISPLAY MESSAGE FROM THE DEVICE CONTRIBUTED TO STAFF MISINTERPRETATION OF RESULTS. IT WAS FURTHER DETERMINED THAT THE ACTUAL DISPLAY FROM THE ACCU-CHEK INFORM II MAY REPRESENT A DESIGN FLAW IN THAT IT DISPLAYS A NUMERICAL VALUE ASSOCIATED WITH AN OUT OF REPORTABLE RANGE MESSAGE THAT WOULD REQUIRE FURTHER MEDICAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44985 ACCU-CHEK INFORM II SYSTEM GLUCOSE DEHYROGENASE, GLUCOSE LFR ROCHE DIAGNOSTICS OPERATIONS, INC. ACCU-CHEK INFORM II

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death MULTIPLE UNITS (DIFFERENT SERIAL NUMBERS) OF THE S