FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 12232737
·
Received July 27, 2021
Report
- Report Number
- 3013756811-2021-78381
- Event Type
- Malfunction
- Date Received
- July 27, 2021
- Date of Event
- July 9, 2021
- Report Date
- July 27, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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 AN OCCLUSION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 250-256 MG/DL. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS OCCLUSION. IN ADDITION, IT WAS REPORTED THAT THE FILL ESTIMATE WAS INACCURATE AND STATIC. CUSTOMER CONTINUED USING THE SAME CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1129528 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |