BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 12862010 · Received November 23, 2021

    Report

    Report Number
    3011393376-2021-03662
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 21, 2021
    Report Date
    November 28, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CATALOG AND UNIQUE IDENTIFIER NUMBERS WERE UPDATED IN SECTION D4.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION WAS PROVIDED ON 02/23/2022. THE PATIENT WENT TO HEALTH FACILITY FOR THERAPY ADJUSTMENT AND IT WAS DETERMINED THAT THE PATIENT IS HIGHLY PRONE FOR STRESS AND THE INFUSION DEVICE WAS WORKING PERFECTLY. THE BLOOD GLUCOSE VALUES IMPROVED AT THE HEALTH FACILITY AND THE PATIENT STILL USES THE INFUSION DEVICE FOR THERAPY.

    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

    ADDITIONAL INFORMATION WAS PROVIDED ON 02/23/2022. THE PATIENT WENT TO HEALTH FACILITY FOR THERAPY ADJUSTMENT AND IT WAS DETERMINED THAT THE PATIENT IS HIGHLY PRONE FOR STRESS AND THE INFUSION DEVICE WAS WORKING PERFECTLY. THE BLOOD GLUCOSE VALUES IMPROVED AT THE HEALTH FACILITY AND THE PATIENT STILL USES THE INFUSION DEVICE FOR THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN HIGH BLOOD GLUCOSE LEVELS OF 528 MG/DL WITH KETONE BODIES OF 3+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758475 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. 05027250001 NA 04015630880119

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female HUMALOG INSULIN