FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10718458
·
Received October 22, 2020
Report
- Report Number
- 3013756811-2020-115333
- Event Type
- Malfunction
- Date Received
- October 22, 2020
- Date of Event
- September 30, 2020
- Report Date
- October 22, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 151-168 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182811 | 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 | 18 YR |