FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6186865
·
Received December 19, 2016
Report
- Report Number
- 3007981285-2016-27375
- Event Type
- Injury
- Date Received
- December 19, 2016
- Date of Event
- December 4, 2016
- Report Date
- December 4, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(BRAND NAME- ADDED "T:SLIM G4 SYSTEM"). (COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP"). (PROCODE- CORRECTED TO "OYC"). (MODEL #- ADDED "4628-003", CATALOG #- ADDED "006194", SERIAL #- ADDED " (B)(4)", (B)(4). PMA/510K #- ADDED "P140015". DEVICE MANUFACTURE DATE- ADDED "1/22/2016".
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 THE CUSTOMER WAS HOSPITALIZED AFTER EXPERIENCING DIABETIC KETOACIDOSIS. NO FURTHER INFORMATION WAS PROVIDED ON THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837796 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R |