FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6012782
·
Received October 7, 2016
Report
- Report Number
- 3007981285-2016-13317
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- September 9, 2016
- Report Date
- September 16, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 500 (MG/DL). A SYRINGE BOLUS WAS DELIVERED TO ADDRESS BG LEVELS. DUE TO OCCLUSION ALARM OCCURRING IN THE PAST AND SUPPLIES BEING CHANGED, TROUBLESHOOTING TO DETERMINE THE SOURCE OF OCCLUSION WAS UNABLE TO BE PERFORMED WITH TANDEM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661751 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other | INFUSION SET: COMFORT SHORT, CONTACT DETACH |