FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6185308
·
Received December 19, 2016
Report
- Report Number
- 3007981285-2016-25890
- Event Type
- Injury
- Date Received
- December 19, 2016
- Date of Event
- November 28, 2016
- Report Date
- December 2, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE OCCLUSION ALARMS OCCURRED DURING BOLUS DELIVERIES. THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS BETWEEN 150-600 (MG/DL) AND "SLIGHT" KETONES. SUPPLIES WERE CHANGED AND INJECTIONS DELIVERED TO ADDRESS BG LEVELS. DUE TO THE OCCLUSIONS OCCURRING IN THE PAST, TROUBLESHOOTING TO DETERMINE THE SOURCE OF THE OCCLUSION COULD NOT BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837398 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |