BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 8883020 · Received August 12, 2019

    Report

    Report Number
    3011393376-2019-02964
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    August 4, 2019
    Report Date
    May 12, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. THE PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE RESULT WAS 33.0 MMOL/L ON AN UNKNOWN DEVICE. THE TYPE OF TREATMENT GIVEN TO THE PATIENT WAS NOT PROVIDED. IT IS UNKNOWN HOW LONG THE PATIENT WAS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679086 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R UNKNOWN INSULIN