FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 7390125
·
Received April 2, 2018
Report
- Report Number
- 3013756811-2018-09997
- Event Type
- Malfunction
- Date Received
- April 2, 2018
- Date of Event
- March 12, 2018
- Report Date
- April 2, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 THE CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETED. SUBSEQUENTLY AFTER POWERING THE PUMP BACK ON, A MALFUNCTION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE WAS 131-133 MG/DL. REPORTEDLY THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231226 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |