FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7935289
·
Received October 4, 2018
Report
- Report Number
- 3013756811-2018-34166
- Event Type
- Malfunction
- Date Received
- October 4, 2018
- Date of Event
- September 2, 2018
- Report Date
- October 4, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257517380
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE INTERMITTENT ALTITUDE ALARMS OCCURRED AFTER THE CUSTOMER HAD EXITED AN AIRPLANE AS WELL AS WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 100-183 MG/DL. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND WAS ABLE TO CLEAR THE ALARM AND RESUME INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776937 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257517380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |