BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20330725 · Received September 30, 2024

    Report

    Report Number
    2032227-2024-246071
    Event Type
    Death
    Date Received
    September 30, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 29, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS NOT FEELING WELL. IT WAS HIGH BLOOD GLUCOSE FROM THE BEGINNING OVER 600 MG/DL. AND TRIED TO DELIVER INSULIN USING THE PUMP BUT IT DID NOT GO DOWN, DECIDED TO USE A SYRINGE. TROUBLESHOOTING WAS PERFORMED. THE PUMP WAS WORN AT THE TIME OF PASSING. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER USING NOT THE MINIMED 670G/770G/780G SYSTEM WITH THE AUTO MODE/SMARTGUARD FEATURE ACTIVE AT THE TIME OF THE HIGH BLOOD GLUCOSE EVENT. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: UNOMEDICAL, MMT-1884L, MMT-332A. NO PRODUCT RETURN WAS REQUIRED FOR UNOMEDICAL. NO PRODUCT RETURN WAS REQUIRED FOR MMT-1884L. NO PRODUCT RETURN WAS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585013 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3524519H

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| D| R FRN-MMT-332A-RSVR, UNOMED INF SET