FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7898761
·
Received September 21, 2018
Report
- Report Number
- 3013756811-2018-33782
- Event Type
- Malfunction
- Date Received
- September 21, 2018
- Date of Event
- August 12, 2018
- Report Date
- September 21, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257539658
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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.
Additional Manufacturer Narrative · 1
THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, NO FAILURE RELATED TO THE REPORTED OCCLUSION ALARM WAS IDENTIFIED.; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-275 MG/DL. REPORTEDLY, THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737962 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257539658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |