FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10174576
·
Received June 19, 2020
Report
- Report Number
- 3013756811-2020-66804
- Event Type
- Malfunction
- Date Received
- June 19, 2020
- Date of Event
- June 8, 2020
- Report Date
- June 19, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 MULTIPLE OCCLUSION ALARMS OCCURRED. SYSTEM CHECK COULD NOT BE PERFORMED WITH TANDEM TECHNICAL SUPPORT, AS THE OCCLUSION ALARMS OCCURRED IN THE PAST. CUSTOMER CHANGED SUPPLIES TO ADDRESS OCCLUSION ALARMS. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL RANGED FROM 180-260 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636792 | 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 | INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG |