FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8455590
·
Received March 27, 2019
Report
- Report Number
- 3013756811-2019-15058
- Event Type
- Malfunction
- Date Received
- March 27, 2019
- Date of Event
- March 8, 2019
- Report Date
- March 27, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 05 AND 06) OCCURRED. REPORTEDLY, THE CUSTOMER HAD FOLLOWED THE PROMPTS WHEN LOADING THE CARTRIDGES AND WAS NOT OUTSIDE THE PUMPS ALLOWABLE ALTITUDE OPERATING RANGE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 123-126 MG/DL. CUSTOMER HAD MANUAL INJECTIONS AVAILABLE FOR ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249606 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |