FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10515655
·
Received September 10, 2020
Report
- Report Number
- 3013756811-2020-98673
- Event Type
- Malfunction
- Date Received
- September 10, 2020
- Date of Event
- August 11, 2020
- Report Date
- September 10, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 AN OCCLUSION ALARM OCCURRED. SYSTEM CHECK COULD NOT BE PERFORMED WITH TANDEM TECHNICAL SUPPORT AS OCCLUSION ALARM OCCURRED IN THE PAST. CUSTOMER CLEARED OCCLUSION ALARM, AND RESUMED INSULIN DELIVERY. CUSTOMER¿S REPORTED BLOOD GLUCOSE LEVEL WAS IN THE 160-185 MG/DL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 980390 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | INFUSION SET: AUTOSOFT 90 |