FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 8822701
·
Received July 24, 2019
Report
- Report Number
- 3013756811-2019-44621
- Event Type
- Malfunction
- Date Received
- July 24, 2019
- Date of Event
- June 30, 2019
- Report Date
- July 24, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 852162004439
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
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 THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, THE CUSTOMER CONTINUED USING THE EXISTING CARTRIDGE FOR INSULIN THERAPY. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. CUSTOMER CHANGED SUPPLIES AND RESUMED INSULIN DELIVERY. BLOOD GLUCOSE WAS 141-162 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614423 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 852162004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | INSULIN: NOVOLOG |