FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9920815
·
Received April 3, 2020
Report
- Report Number
- 3013756811-2020-34452
- Event Type
- Malfunction
- Date Received
- April 3, 2020
- Date of Event
- March 13, 2020
- Report Date
- April 3, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 THAT MULTIPLE OCCLUSION ALARMS OCCURRED. CUSTOMER REPORTED USING FIASP INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT FIASP IS OFF LABEL PER THE USER GUIDE. CUSTOMER CHANGED OUT INFUSION SET TO ADDRESS THE ALARM AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 100-233 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384095 | 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 | 20 YR |