BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 13845651 · Received March 22, 2022

    Report

    Report Number
    3011393376-2022-00879
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    March 8, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    UDI-DI
    04015630880119
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS OF 27.5 MMOL/L - HI MMOL/L (READING HIGHER THAN THE READING RANGE OF THE METER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36096 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. 05027250001 NA 04015630880119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female UNKNOWN INSULIN