FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8922860
·
Received August 22, 2019
Report
- Report Number
- 3013756811-2019-51237
- Event Type
- Malfunction
- Date Received
- August 22, 2019
- Date of Event
- July 28, 2019
- Report Date
- August 22, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT INSULIN DRIPS WERE INTERMITTENTLY NOT OBSERVED TO BE DRIPPING OUT OF THE INFUSION SET TUBING AND MULTIPLE CARTRIDGE TUBINGS DURING THE LOAD FILL TUBING SEQUENCE. MULTIPLE SUPPLY CHANGES WERE PERFORMED AND THE ISSUE CONTINUED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 130-147 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714333 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG |