FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9252644
·
Received October 29, 2019
Report
- Report Number
- 3013756811-2019-72974
- Event Type
- Malfunction
- Date Received
- October 29, 2019
- Date of Event
- October 10, 2019
- Report Date
- October 29, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007318
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER TANDEM¿S T:SLIM X2 G5 USER GUIDE: "TAP CLOSE. CHANGE THE CARTRIDGE, TUBING, AND INFUSION SITE TO ENSURE PROPER DELIVERY OF INSULIN. RESUME INSULIN AFTER CHANGING THE CARTRIDGE, TUBING, AND INFUSION SITE." 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-320 MG/DL. REPORTEDLY, THE ALARMS WERE CLEARED AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044176 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |