FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 11076786
·
Received December 28, 2020
Report
- Report Number
- 3013756811-2020-147958
- Event Type
- Malfunction
- Date Received
- December 28, 2020
- Date of Event
- December 9, 2020
- Report Date
- December 28, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
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 AND EVALUATION IS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALTITUDE ALARM INTERMITTENTLY OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120-280 MG/DL. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND RESUMED INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1544908 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | INSULIN: NOVOLOG, INFUSION SET: AUTOSOFT 90| INSULIN: NOVOLOG, INFUSION SET: AUTOSOFT 90 |