BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 8905975 · Received August 19, 2019

    Report

    Report Number
    3011393376-2019-03043
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Report Date
    November 1, 2019
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699206 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR UNKNOWN INSULIN