FDA Adverse Event
Malfunction
Summary report: N
GLOOKO
MDR report key: 20463380
·
Received October 15, 2024
Report
- Report Number
- MW5161102
- Event Type
- Malfunction
- Date Received
- October 15, 2024
- Date of Event
- September 3, 2024
- Report Date
- November 21, 2024
- Manufacturer
- GLOOKO INC.
- Product Code
- PHV
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 11/21/2024 FOR REPORT NUMBER MW5161102. PROCODE CHANGE TO PHV.
Description of Event or Problem · 0
THIS PATIENT IS USING THE OMNIPOD 5 AUTOMATED INSULIN PUMP SYSTEM, AND IT WAS DISCOVERED THAT THERE WAS, WHAT APPEARS TO BE, A GLITCH IN THE SETTINGS PROFILE ON THE GLOOKO GLUCOSE MANAGEMENT CLOUD SYSTEM. THERE IS AN ADDITIONAL BASAL RATE PROFILE ON THE GLOOKO REPORT THAT IS INCORRECT, DOES NOT BELONG TO THE PATIENT, AND IS NOT IN THEIR INSULIN PUMP CONTROLLER. THE CORRECT AMOUNT OF INSULIN IS BEING DELIVERED, BUT A DIFFERENT PROFILE IS SHOWING UP IN THE GLOOKO CLOUD SYSTEM. THIS HAS BEEN DISCOVERED IN (B)(4) PATIENTS SO FAR IN OUR CLINIC (WILL BE ENTERED AS SEPARATE PATIENTS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2270894 | GLOOKO | CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE | PHV | GLOOKO INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Female | OMNIPOD 5. |