FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 7333865
·
Received March 13, 2018
Report
- Report Number
- 3013756811-2018-07364
- Event Type
- Malfunction
- Date Received
- March 13, 2018
- Date of Event
- February 3, 2018
- Report Date
- March 13, 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 RECEIVED MULTIPLE INTERMITTENT CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 141-251 MG/DL. THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE AND CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY.
Description of Event or Problem · 1
THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 141-215 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177434 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |