FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6050676
·
Received October 24, 2016
Report
- Report Number
- 3007981285-2016-15330
- Event Type
- Injury
- Date Received
- October 24, 2016
- Date of Event
- October 1, 2016
- Report Date
- October 1, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 PUMP COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE USB CABLES, WALL ADAPTERS AND POWER SOURCES. IT WAS CONFIRMED THAT THE CHARGING SUPPLIES WERE ABLE TO SUCCESSFULLY CHARGE ANOTHER DEVICE. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED (312 MG/DL). A CORRECTION BOLUS WAS DELIVERED TO ADDRESS ELEVATED BG LEVEL. IT WAS INDICATED THAT THE CUSTOMER WOULD CONTINUE TO USE THE PUMP UNTIL THE REPLACEMENT PUMP WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701089 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Other |