FDA Adverse Event
Malfunction
Summary report: N
GLOOKO DEVICE SYSTEM
MDR report key: 8504758
·
Received April 11, 2019
Report
- Report Number
- 3009137498-2019-00006
- Event Type
- Malfunction
- Date Received
- April 11, 2019
- Date of Event
- March 14, 2019
- Report Date
- April 11, 2019
- Manufacturer
- GLOOKO INC
- Product Code
- JQP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A HCP USER REPORTED THAT AFTER UPLOADING A DIABETES DEVICE VIA THE GLOOKO TRANSMITTER, THE DEVICE OFFSET LABEL ON THE GLOOKO WEB APPLICATION IS NOT DISPLAYING THE CORRECT OFFSET INFORMATION. NO ADVERSE EVENT WAS REPORTED. THE GLOOKO ENGINEERING TEAM WAS ABLE TO REPRODUCE THE ISSUE AND A SOFTWARE FIX WILL BE IMPLEMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298626 | GLOOKO DEVICE SYSTEM | GLOOKO WEB APPLICATION | JQP | GLOOKO INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |