FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7265054
·
Received February 12, 2018
Report
- Report Number
- 3013756811-2018-04169
- Event Type
- Malfunction
- Date Received
- February 12, 2018
- Date of Event
- January 20, 2018
- Report Date
- February 12, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE IS EXPECTED TO BE RETURNED; HOWEVER, IT HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE CARTRIDGE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INACCURATE FILL ESTIMATE. THE CUSTOMER LOADED ANOTHER CARTRIDGE AND RECEIVED AN ACCURATE READING. BLOOD GLUCOSE WAS 143-144 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108444 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | M021085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |