FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9311165
·
Received November 12, 2019
Report
- Report Number
- 3013756811-2019-80159
- Event Type
- Malfunction
- Date Received
- November 12, 2019
- Date of Event
- October 28, 2019
- Report Date
- November 12, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 THE INSULIN GAUGE WAS INACCURATE AFTER FILLING THE CARTRIDGE WITH 250 UNITS. ADDITIONALLY, IT WAS REPORTED THAT A OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 110-255 MG/DL. REPORTEDLY, THE CUSTOMER RELOADED THE CARTRIDGE AND CHANGED INFUSION SET TO RESOLVE THE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1106709 | 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 | 49 YR |