FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 8889240
·
Received August 13, 2019
Report
- Report Number
- 3013756811-2019-49218
- Event Type
- Malfunction
- Date Received
- August 13, 2019
- Date of Event
- July 20, 2019
- Report Date
- August 13, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004576
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 TO USE THE EXISTING CARTRIDGE FOR INSULIN THERAPY. ADDITIONALLY, AN OCCLUSION ALARM OCCURRED. CUSTOMER ACKNOWLEDGE THE ALARM AND RESUMED INSULIN DELIVERY. CUSTOMER¿S BLOOD GLUCOSE WAS 200-303 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682004 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |