FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9268907
·
Received November 1, 2019
Report
- Report Number
- 3013756811-2019-73305
- Event Type
- Malfunction
- Date Received
- November 1, 2019
- Date of Event
- October 11, 2019
- Report Date
- November 1, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007318
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE USB CABLES, WALL ADAPTERS AND POWER SOURCES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 121-200 (MG/DL). REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1061694 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |