MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-247201
- Event Type
- Injury
- Date Received
- October 1, 2024
- Date of Event
- July 15, 2024
- Report Date
- December 12, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
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.
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.
UPDATED SUMMARY: IT WAS REPORTED THAT EMERGENCY MEDICAL SERVICES WERE DISPATCHED ON JUL. 15, 2024 DUE TO HYPOGLYCEMIA, THE LOW BLOOD GLUCOSE EVENT WAS SEVERE ENOUGH TO LEAD TO NEAR-COMATOSE STATUS, CUSTOMER DID NOT KNOW EXACT DATE. USER STATED BLOOD GLUCOSE AT TIME OF EVENT WAS 30 MG/DL BUT THEY DID NOT REMEMBER EXACT VALUE. AT THE EMERGENCY ROOM THEY WERE TREATED WITH INTRAVENOUS GLUCOSE. WHEN ASKED WHAT LED TO EVENT, THEY STATED SG V BG DIFFERENCE. SENSOR GLUCOSE AT TIME OF EVENT WAS 70 MG/DL. WHEN ASKED IF THEY WERE TAKING MEDICATION, THEY STATED EXCEDRIN (HAS ACETAMINOPHEN).
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED SENSOR GLUCOSE VS. BLOOD GLUCOSE. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 30 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH EMERGENCY MEDICAL SERVICES AND GLUCOSE/CARB INTAKE; COMA TREATED WITH EMERGENCY MEDICAL SERVICES. THE EVENT INVOLVED PRODUCT(S) MMT-441A, MMT-342, MMT-7040A, MMT-1884. CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-441A. NO PRODUCT RETURN IS REQUIRED FOR MMT-342. PRODUCT RETURN REQUESTED FOR MMT-7040A. CUSTOMER DECLINED TO RETURN, OR IS UNABLE TO RETURN. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1916017 | 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 | NG3624607H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention| O | FRN-MMT-342-RSVR,UNOMED INF SET,OZP-MMT-7040-SNSR |