BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7721620 · Received July 26, 2018

    Report

    Report Number
    3004209178-2018-95938
    Event Type
    Death
    Date Received
    July 26, 2018
    Date of Event
    May 11, 2018
    Report Date
    October 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FRN- MODEL UNKNOWN ¿ RESERVOIR. THE NEXT OF KIN CALLED AND STATED THAT THE PUMP WAS RELEASING TOO MUCH INSULIN AND HAD A CANNULA ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS UNDETERMINED NATURAL CAUSES. THE CALLER STATED THAT THE CUSTOMER HAD HYPERTENSION THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CALLER WAS UNSURE IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER HAD ISSUES WITH THE PUMP AND WAS ON AND OFF THE PUMP. THE CUSTOMER WAS WORKING WITH AN EDUCATOR DUE TO THE MULTIPLE ISSUES, BUT PASSED BEFORE MEETING WITH THE EDUCATOR. THE CALLER IS UNSURE IF THE CUSTOMER WAS USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Description of Event or Problem · 1

    FRN- MODEL UNKNOWN ¿ RESERVOIR. THE NEXT OF KIN CALLED AND STATED THAT THE PUMP WAS RELEASING TOO MUCH INSULIN AND HAD A CANNULA ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565797 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG244KA 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death FRN- MODEL UNKNOWN ¿ RESERVOIR