FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8584585
·
Received May 6, 2019
Report
- Report Number
- 3013756811-2019-23645
- Event Type
- Malfunction
- Date Received
- May 6, 2019
- Date of Event
- February 1, 2019
- Report Date
- May 6, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007271
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TANDEM¿S USER GUIDE DESCRIBES HOW TO REMOVE AIR FROM THE CARTRIDGE USING THE SYRINGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER OBSERVED AIR BUBBLES WITHIN THE TUBING. REPORTEDLY, THE CUSTOMER DOES NOT PERFORM THE AIR REMOVAL PROCESS DURING THE LOAD SEQUENCE. A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE AIR BUBBLES. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 250-380 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374560 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |