FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 6102784
·
Received November 15, 2016
Report
- Report Number
- 3007981285-2016-18984
- Event Type
- Malfunction
- Date Received
- November 15, 2016
- Date of Event
- October 25, 2016
- Report Date
- October 25, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP COULD NOT BE CHARGED DESPITE THE ATTEMPT OF MULTIPLE USB CABLES AND POWER SOURCES. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL WAS 150 (MG/DL). REPORTEDLY, THE CUSTOMER HAS MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 753974 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |