FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8841525
·
Received July 30, 2019
Report
- Report Number
- 3013756811-2019-46919
- Event Type
- Malfunction
- Date Received
- July 30, 2019
- Date of Event
- July 8, 2019
- Report Date
- July 30, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY WAS DEPLETING QUICKLY, A CARTRIDGE ALARM 1 OCCURRED, AND A MINIMUM FILL MESSAGE OCCURRED AFTER THE CARTRIDGE WAS FILLED WITH 250 UNITS. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 233-247 MG/DL. CUSTOMER REVERTED TO MANUAL INJECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635698 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000354 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |