FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6026350
·
Received October 13, 2016
Report
- Report Number
- 3007981285-2016-13930
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- September 21, 2016
- Report Date
- September 21, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 AN OCCLUSION ALARM OCCURRED DURING BASAL DELIVERY. THE CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVELS BETWEEN 233-500 (MG/DL). THE INFUSION SITE WAS CHANGED AND A BOLUS DELIVERED TO ADDRESS BG LEVELS. DUE TO THE SUPPLIES BEING CHANGED, TROUBLESHOOTING TO DETERMINE THE SOURCE OF THE OCCLUSION WAS UNABLE TO BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679400 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |