FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 12259223
·
Received August 2, 2021
Report
- Report Number
- 3013756811-2021-86341
- Event Type
- Malfunction
- Date Received
- August 2, 2021
- Date of Event
- July 19, 2021
- Report Date
- August 2, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED OCCLUSION ALARMS AND RESUMED INSULIN DELIVERY OR THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE 202-237 MG/DL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1157108 | 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 | 49 YR | INSULIN: HUMALOG |