BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19244759 · Received May 4, 2024

    Report

    Report Number
    2032227-2024-163259
    Event Type
    Injury
    Date Received
    May 4, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0869 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND STAINED KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE DATA PERTAINING TO THE PRIMARY SVN (B)(4) AND EVENT DATE 08-APR-2024 BELOW. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 08-APR-2024 IN THE PUMP HISTORY FILE ON THE PRIMARY SVN (B)(4). 04/08/2024 04:11:03.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1). NORMALBOLUSAMOUNTPROGRAMMED: 15000 (1.5 U). BOLUSAMOUNTDELIVERED: 15000 (1.5 U). 04/08/2024 09:06:29.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 83000 (8.3 U), BOLUSAMOUNTDELIVERED: 83000 (8.3 U). 04/08/2024 14:59:45.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 90000 (9 U), BOLUSAMOUNTDELIVERED: 90000 (9 U). 04/08/2024 16:10:13.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 33000 (3.3 U), BOLUSAMOUNTDELIVERED: 33000 (3.3 U). 04/08/2024 19:05:39.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 80000 (8 U), BOLUSAMOUNTDELIVERED: 37500 (3.75 U). 04/08/2024 19:07:36.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 101000 (10.1 U), BOLUSAMOUNTDELIVERED: 4000 (0.4 U). 04/08/2024 19:25:11.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 116000 (11.6 U), BOLUSAMOUNTDELIVERED: 116000 (11.6 U). 04/08/2024 22:50:45.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 40000 (4 U), BOLUSAMOUNTDELIVERED: 40000 (4 U). 04/09/2024 06:25:33.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 51000 (5.1 U), BOLUSAMOUNTDELIVERED: 51000 (5.1 U). 04/09/2024 07:10:19.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 50000 (5 U), BOLUSAMOUNTDELIVERED: 26500 (2.65 U). THERE WERE NO AUTOSUSPEND (12) ALARM LISTED IN THE PUMP HISTORY FILE. 04/08/2024 19:12:22.000 INSULINDELIVERYSTOPPED (30), REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE 08-APR-2024 IN THE PUMP HISTORY FILE ON THE PRIMARY SVN (B)(4). 04/08/2024 19:12:22.000 INSULINDELIVERYSTOPPED (30). REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 08-APR-2024 IN THE PUMP HISTORY FILE ON THE PRIMARY SVN (B)(4). 04/08/2024 19:05:39.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: NODELIVERY (7) - DURING BOLUS. 04/08/2024 19:07:36.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: NODELIVERY (7) - DURING BOLUS. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. NODELIVERY (7) - NOT CONFIRMED. PLEASE SEE DATA PERTAINING TO SVN (B)(4) AND EVENT DATE 29-APR-2024 BELOW. PLEASE SEE BELOW FOR THE USERTIMEDATECHANGE (3) LISTED IN THE PUMP HISTORY FILE. 04/12/2024 10:53:48.000 USERTIMEDATECHANGE (3). SYSTEMTIME = 04/12/2024 10:53:48.000. NEWSYSTEMTIME: 05/02/2024 08:29:49.000. THERE WAS NO DATA AVAILABLE ON 29-APR-2024 IN THE PUMP HISTORY FILE ON SVN (B)(4). UNABLE TO VERIFY BOLUS DELIVERY, SOURCE OF BOLUSES DELIVERED, AND ANY ALARMS/SUSPENDS FOR EVENT DATE 29-APR-2024 DUE TO NO DATA AVAILABLE IN THE PUMP HISTORY FILE ON SVN (B)(4). UNABLE TO PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 29-APR-2024 IN THE PUMP HISTORY FILE DUE TO NO DATA AVAILABLE ON SVN (B)(4). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOT CONFIRMED. 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.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 EXPERIENCED AN INSULIN FLOW BLOCKED ALARM. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA, TREATED WITH MANUAL INJECTION/INSULIN PEN, HOSPITALIZATION, AND FELT FATIGUE. THE TROUBLESHOOTING WAS PERFORMED, CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: CHANGING SET AND SITE. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-1884, AND MMT-399A. THE CUSTOMER WAS NOT USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-399A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100551 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 HG69RMEZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H| O FRN-MMT-332A- RSVR, UNOMED SET.