MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2024-127183
- Event Type
- Injury
- Date Received
- February 16, 2024
- Date of Event
- January 30, 2024
- Report Date
- February 16, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WAS TRAINED ON 780G ON (B)(6) 2024. THE CUSTOMER WAS PREVIOUSLY ON MULTIPLE DAILY INJECTION (MDI) AND STATED THEIR DIABETES WAS POORLY CONTROLLED. ACCORDING TO THE PATIENT THEY HAD BEEN IN THE HOSPITAL SEVERAL TIMES IN THE PAST FEW MONTHS FOR AN INSULIN DRIP. CUSTOMER WAS FRUSTRATED AT THE APPOINTMENT BECAUSE THEIR CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE WAS NOT AVAILABLE AS IT HAD TO BE OBTAINED FROM A DISTRIBUTOR AND THERE WERE ISSUES WITH THIS PROCESS. PER DOCTOR'S ORDERS, THEY STARTED ON 780G AND WAS INSTRUCTED TO USE FINGER STICKS. THE PHYSICIAN PROVIDED A PERSONALIZED SLIDING SCALE INSULIN FOR CORRECTIONS. CUSTOMER STATED THEY ONLY EATS ONCE EVERY 3 DAYS DUE TO PANCREATITIS. SO THEY WERE GIVEN A SLIDING SCALE THAT WAS APPROPRIATE WITH AND WITHOUT FOOD. CUSTOMER DID WELL DURING THE TRAINING AND WAS ABLE TO DEMONSTRATE HOW TO USE THE PUMP DURING APPOINTMENT. CUSTOMER TOLD THAT THEY TOOK THE PUMP OFF A FEW HOURS AGO AND WAS GOING TO WITHDRAWAL ALL MEDICAL TREATMENT, INCLUDING OTHER TREATMENTS THAT HAD NOTHING TO DO WITH THEIR DIABETES. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE OR NOT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432215 | 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 | NG3674224H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention| H| O | FRN-332-RSVR, UNOMED INF SET |