FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 6173568
·
Received December 14, 2016
Report
- Report Number
- 3007981285-2016-25179
- Event Type
- Malfunction
- Date Received
- December 14, 2016
- Date of Event
- November 27, 2016
- Report Date
- November 27, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
TIME ISSUE- NO FAILURE 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 THE PUMP UNEXPECTEDLY SHUTDOWN. REPORTEDLY, AFTER APPROXIMATELY 10 MINUTES THE PUMP TURNED BACK ON. CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE ONTO THE PUMP AND RESUME INSULIN DELIVERY. IN ADDITION, THE PUMP TIME WAS INACCURATE. REPORTEDLY, THE AM/PM TIME SETTINGS WERE PROGRAMMED INCORRECTLY. TANDEM TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH ADJUSTING THE AM/PM SETTINGS. CUSTOMER STATED THEY HAVE A BACK UP METHOD FOR CONTINUED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824558 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |