FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9809041
·
Received March 9, 2020
Report
- Report Number
- 3013756811-2020-22411
- Event Type
- Malfunction
- Date Received
- March 9, 2020
- Date of Event
- February 15, 2020
- Report Date
- March 9, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER TANDEM USER GUIDE: "CHECK THE CARTRIDGE, TUBING, AND INFUSION SITE FOR ANY SIGN OF DAMAGE OR BLOCKAGE AND CORRECT THE CONDITION." 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 THE MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 120-270 MG/DL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN DELIVERY TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268159 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |