BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER (PDM)

    MDR report key: 16731889 · Received April 12, 2023

    Report

    Report Number
    MW5116592
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 11, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING TO REPORT PROBLEMS CONTROLLING HIS BLOOD SUGARS USING THE CLOSED LOOP SYSTEM OF HIS OMNIPOD 5 AND DEXCOM G6. REPORTER STATES HE IS HAVING PROBLEMS DAILY AND HAS EXPERIENCED BOTH HYPERGLYCEMIA AND HYPOGLYCEMIA AS A RESULT OF DEVICE-RELATED PROBLEMS. ON (B)(6) 2023, REPORTER RECEIVED A "POD ERROR" AND STATES THE CONTROLLER WOULD NOT COMMUNICATE WITH THE POD, AS WELL AS OTHER POD FAILURES WHEN THE POD IS "LESS THAN 24 HOURS OLD". HE ALSO EXPLAINS THAT HIS DEXCOM G6 GIVES "CONFUSING" NOTIFICATIONS AND IS NOT VERY USER FRIENDLY. REPORTER STATES HE WAS DIAGNOSED WITH TYPE 1 DIABETES AT THE AGE OF THREE, AND HE IS VERY FAMILIAR WITH HOW THESE DEVICES ARE SUPPOSED TO FUNCTION. REPORTER STATES HE HAS CONTACTED BOTH INSULET CORPORATION AND DEXCOM REGARDING THESE PROBLEMS BUT "THEY DO NOT WANT TO FIX THIS. "REPORTER STATES THAT WHEN HE IS PHYSICALLY ACTIVE OUTDOORS THAT THE PDM (PERSONAL DIABETES MANAGER) "SHUTS DOWN" AND THEN "THE PUMP CANNOT FIGURE OUT WHAT TO DO". REPORTER EXPRESSES HIS FRUSTRATION AND WANTS INSULET CORPORATION AND DEXCOM TO "JUST FIX YOUR PRODUCTS". REFERENCE REPORTS: MW5116591, MW5116593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250074 OMNIPOD 5 CONTROLLER (PDM) INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER QJI INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other| L