FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 9758337
·
Received February 26, 2020
Report
- Report Number
- 3013756811-2020-18694
- Event Type
- Malfunction
- Date Received
- February 26, 2020
- Date of Event
- February 8, 2020
- Report Date
- February 26, 2020
- 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
THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS VERIFIED. NO FAILURE RELATED TO THE REPORTED STORAGE MODE ISSUE WAS IDENTIFIED.
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 162-271 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO ALTERNATE INSULIN THERAPY FOR DIABETES MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217239 | 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 | 62 YR |