BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI

    MDR report key: 23693090 · Received December 2, 2025

    Report

    Report Number
    MW5179682
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 25, 2025
    Report Date
    November 25, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE THE TANDEM MOBI PUMP WITH CONTROL IQ. I PROGRAMMED THE PUMP TO GIVE 2.5 UNITS OF INSULIN FOR A MEAL (AND MY BLOOD GLUCOSE WAS 56 AT THAT TIME. THE PUMP GAVE 25 UNITS OF INSULIN AND I HAD A SEVERE HYPOGLYCEMIC EVENT. (IT SHOULD NOT HAVE GIVEN THAT MUCH AS IT HAS A BUILT-IN ALERT THAT SAYS IT CANNOT GIVE THAT MUCH INSULIN IF BLOOD GLUCOSE IS ALREADY LOW). WHILE I SAW WHAT HAD HAPPENED, IT WAS NOT POSSIBLE TO EAT ENOUGH SUGAR QUICKLY ENOUGH TO PREVENT THE HYPOGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864512 MOBI ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. 1004000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Life Threatening ASPIRIN 81 MG. | BUPROPION XL300 MG. | ESCITALOPRAM 15 MG.| HUMALOG INSULIN. | MANNOSE-CRANBERRY. | OLMESARTAN 10 MG.| OMEGA FATTY ACIDS.| PSYLLIUM HUSK. | ROSUVASTATIN 10 MG. | TANDEM MOBI. | ZINC.