FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6099821
·
Received November 14, 2016
Report
- Report Number
- 3007981285-2016-20163
- Event Type
- Malfunction
- Date Received
- November 14, 2016
- Date of Event
- October 26, 2016
- Report Date
- October 26, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. CUSTOMER REPORTED BLOOD GLUCOSE LEVELS BETWEEN 133-140 (MG/DL). IT WAS REPORTED THAT THE CUSTOMER WOULD OBTAIN INSULIN INJECTIONS FOR ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750660 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |