FDA Adverse Event
Injury
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 12578182
·
Received October 5, 2021
Report
- Report Number
- 3013756811-2021-106473
- Event Type
- Injury
- Date Received
- October 5, 2021
- Date of Event
- September 9, 2021
- Report Date
- October 5, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007295
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS ONLY ABLE TO SUCCESSFULLY FILL THE CARTRIDGE WITH 280 UNITS OF INSULIN OUT OF 300 UNITS OF INSULIN, AND SUBSEQUENTLY EXPERIENCED FILL RESISTANCE. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 200-542 MG/D. A BOLUS WAS DELIVERED AND AN INFUSION SET CHANGE TO ADDRESS BG LEVEL. THE CUSTOMER CONTINUED TO USE THE CARTRIDGE AND WAS ABLE TO SUCCESSFULLY RESUME INSULIN DELIVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1472754 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | M878230 | 00853052007295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other | INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90 |