BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 18817980 · Received March 1, 2024

    Report

    Report Number
    3011393376-2024-00526
    Event Type
    Injury
    Date Received
    March 1, 2024
    Report Date
    May 28, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 CUSTOMER WAS ADMITTED TO HOSPITAL WITH KETOACIDOSIS AND UNCONSCIOUSNESS. THE RESPONSIBLE DIABETOLOGIST CHECKED THE PUMP AND OBSERVED INSULIN COMING OUT OF THE END OF THE TUBING AFTER A BOLUS DELIVERY. AFTER REUSE OF THE INSULIN PUMP, THE CUSTOMER´S BLOOD GLUCOSE LEVELS WERE RISING AGAIN. THE HEALTH CARE PROFESSIONAL FOUND AIR BUBBLES IN THE CARTRIDGE AND ASSUMES THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN. AT THE TIME THE HEALTH CARE PROFESSIONAL REPORTED THE ISSUE, THE CUSTOMER WAS STILL IN THE HOSPITAL. NO MORE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932644 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Hospitalization| R UNKNOWN INSULIN