FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 5224585
·
Received November 15, 2015
Report
- Report Number
- 3007981285-2015-59394
- Event Type
- Malfunction
- Date Received
- November 15, 2015
- Date of Event
- October 31, 2015
- Report Date
- October 31, 2015
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M013962). 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.
Additional Manufacturer Narrative · 1
THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE CUSTOMER COMPLAINT WAS VERIFIED. IN ADDITION, A DIFFERENT ISSUE WAS FOUND.
Description of Event or Problem · 1
RECEIVED INFORMATION REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BOLUS DELIVERY. AFTER REQUESTING A BOLUS, THE CUSTOMER INDICATED THAT THERE WAS A GRINDING SOUND ABOUT HALF WAY THROUGH THE FILL TUBING PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. IT WAS CONFIRMED THAT THE CUSTOMER HAD MANUAL INSULIN INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 753884 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | M015599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |