FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 8250867
·
Received January 15, 2019
Report
- Report Number
- 3013756811-2019-02054
- Event Type
- Malfunction
- Date Received
- January 15, 2019
- Date of Event
- October 1, 2018
- Report Date
- January 15, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS VERIFIED AND A DIFFERENT ISSUE WAS IDENTIFIED.
Additional Manufacturer Narrative · 1
(B)(4). CARTRIDGE LOT NUMBERS: M122656, M021877, M021576, M021729, M021159, M021404, M021365, M021908, M015351, M022025.
Additional Manufacturer Narrative · 1
THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS VERIFIED AND A DIFFERENT ISSUE WAS IDENTIFIED.
Description of Event or Problem · 1
QUARTERLY SUMMARY REPORT FOR ALLEGED OCCLUSION ALARMS. IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. ISSUE WAS RESOLVED BY CLEARING THE ALARM, CHANGING SUPPLIES, SWITCHING TO LABELED INSULIN, OR REVERTING TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43662 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |