FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9126394
·
Received September 26, 2019
Report
- Report Number
- 3013756811-2019-61632
- Event Type
- Malfunction
- Date Received
- September 26, 2019
- Date of Event
- September 4, 2019
- Report Date
- September 26, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 CUSTOMER EXPERIENCED DIFFICULTY CHARGING THE PUMP WITH THE USB CABLE WHICH RESULTED IN THE BATTERY FULLY DEPLETING AND THE PUMP SHUTTING DOWN. THE PUMP WAS ABLE TO BE CHARGED SUCCESSFULLY WITH AN ALTERNATE USB CABLE. BLOOD GLUCOSE LEVEL WAS 172-179 MG/DL. REPLACEMENT CABLE SENT TO CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917498 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000354 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |