FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 9373131
·
Received November 25, 2019
Report
- Report Number
- 3013756811-2019-81787
- Event Type
- Malfunction
- Date Received
- November 25, 2019
- Date of Event
- November 4, 2019
- Report Date
- November 25, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING. A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 251-433 MG/DL. A MANUAL INJECTION WAS ADMINISTERED TO ADDRESS BG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165853 | T:SLIM X2 INSULIN PUMP | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |