FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10976261
·
Received December 9, 2020
Report
- Report Number
- 3013756811-2020-140868
- Event Type
- Malfunction
- Date Received
- December 9, 2020
- Date of Event
- November 22, 2020
- Report Date
- December 9, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613021
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 AND EVALUATION IS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT MULTIPLE TEMPERATURE ALARMS OCCURRED. CUSTOMER WAS UNABLE TO CLEAR THE ALARMS AND REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 162-253 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1441026 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF |