FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 11777056
·
Received May 5, 2021
Report
- Report Number
- 3013756811-2021-50249
- Event Type
- Malfunction
- Date Received
- May 5, 2021
- Date of Event
- April 15, 2021
- Report Date
- May 5, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004569
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 150-336 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673333 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | INFUSION SET: AUTOSOFT 90INSULIN: ASPART |