FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 12253695
·
Received July 30, 2021
Report
- Report Number
- 3013756811-2021-80228
- Event Type
- Malfunction
- Date Received
- July 30, 2021
- Date of Event
- July 9, 2021
- Report Date
- July 30, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00085006613373
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 103-105 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY AND HAD MANUAL INJECTIONS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1152342 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00085006613373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90| INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90 |