FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9597260
·
Received January 16, 2020
Report
- Report Number
- 3013756811-2020-04359
- Event Type
- Malfunction
- Date Received
- January 16, 2020
- Date of Event
- December 27, 2019
- Report Date
- January 16, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007301
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 PUMP INSULIN GAUGE WAS INACCURATE AND AN OCCLUSION ALARM OCCURRED DURING BOLUS DELIVERY. CUSTOMER RESUMED INSULIN DELIVERY AND THE REMAINDER OF THE BOLUS WAS DELIVERED. REPORTEDLY, CUSTOMER LOADED ANOTHER CARTRIDGE AND INFUSION SET TO RESOLVE THE ISSUES. CUSTOMER'S BLOOD GLUCOSE WAS 140-238 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59997 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG |