FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 10316917
·
Received July 23, 2020
Report
- Report Number
- 3013756811-2020-76777
- Event Type
- Malfunction
- Date Received
- July 23, 2020
- Date of Event
- July 3, 2020
- Report Date
- July 23, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007318
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT MALFUNCTION ALARMS OCCURRED. IN ADDITION, IT WAS REPORTED AN OCCLUSION ALARM OCCURRED. CUSTOMER DECLINED TROUBLESHOOTING FOR THE REPORTED OCCLUSION WITH TANDEM TECHNICAL SUPPORT. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 173-264 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781034 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |