FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8501993
·
Received April 10, 2019
Report
- Report Number
- 3013756811-2019-20307
- Event Type
- Malfunction
- Date Received
- April 10, 2019
- Date of Event
- March 19, 2019
- Report Date
- April 10, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 BATTERY WAS DEPLETING QUICKLY WHICH RESULTED IN THE PUMP SHUTTING DOWN. THE CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 200-291 (MG/DL). MULTIPLE FOLLOW UP ATTEMPTS WERE MADE TO COMPLETE TROUBLESHOOTING WITH THE CUSTOMER; HOWEVER, THE CUSTOMER DID NOT RESPOND TO FOLLOW UP ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292006 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |