FDA Adverse Event
Injury
Summary report: N
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
MDR report key: 13437703
·
Received February 3, 2022
Report
- Report Number
- 2032227-2022-108614
- Event Type
- Injury
- Date Received
- February 3, 2022
- Date of Event
- January 27, 2022
- Report Date
- February 3, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 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.
Description of Event or Problem · 0
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CURRENT BLOOD GLUCOSE LEVEL WAS 456 MG/DL. CUSTOMER WAS UNABLE TO CALIBRATE DUE TO HIGH BLOOD GLUCOSE LEVELS. THE AUTO MODE WAS NOT ACTIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, FRN- UNOMED SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176093 | MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1880 | HG5BEWRZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Other | FRN-UNK-RSVR, FRN- UNOMED SET |