FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 8971214
·
Received September 6, 2019
Report
- Report Number
- 3013756811-2019-56524
- Event Type
- Malfunction
- Date Received
- September 6, 2019
- Date of Event
- August 16, 2019
- Report Date
- September 6, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004385
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 1) WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERY. MULTIPLE CARTRIDGE CHANGES WERE PERFORMED RESOLVING THE ALARMS. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 100-242 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766553 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | INFUSION SET: TRUSTEEL INSULIN: NOVOLOG/NOVORAPID |