FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 7541531
·
Received May 24, 2018
Report
- Report Number
- 3013756811-2018-17771
- Event Type
- Malfunction
- Date Received
- May 24, 2018
- Date of Event
- March 11, 2018
- Report Date
- May 24, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT
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 THERE WERE MULTIPLE, INTERMITTENT EVENTS IN WHICH THE PUMP BATTERY WAS OBSERVED TO BE DEPLETING QUICKLY. AT TIMES, THE BATTERY DEPLETING QUICKLY LED TO THE PUMP TURNING OFF. BLOOD GLUCOSE LEVEL RANGED BETWEEN 190-299 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384270 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |