OMNIPOD 5 APP
Report
- Report Number
- 3004464228-2023-06694
- Event Type
- Injury
- Date Received
- March 10, 2023
- Date of Event
- February 28, 2023
- Report Date
- March 1, 2023
- Manufacturer
- INSULET CORPORATION
- Product Code
- QFG
- UDI-DI
- 10385081120302
- PMA / PMN Number
- K203768
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
WE ORIGINALLY RECEIVED THE PATIENT'S PERSONAL DIABETES MANAGER FOR INVESTIGATION. UPON FURTHER REVIEW, IT WAS IDENTIFIED THAT THE ALLEGATION WAS MADE AGAINST THE PHONE APP RATHER THAN THE RETURNED LOCKDOWN CONTROLLER, THE SERIAL NUMBER WAS UPDATED APPROPRIATELY TO REFLECT THIS.UPDATED THE DEVICE TO OMNIPOD 5 APP. MEDICAL DEVICE PROBLEM CODE CHANGED TO APPLICATION PROGRAM PROBLEM.
BASED OFF OF CASE DETAILS, IT WAS DETERMINED THAT THIS WAS NOT A COMPLAINT LINKED TO THE RETURNED DEVICE. THE SERIAL NUMBER RECORDED IS FOR A PHYSICAL CONTROLLER, BUT THE COMPLAINT WAS ABOUT THE SMARTPHONE APP. THE USER PROVIDED THE INCORRECT SERIAL. NO INVESTIGATION IS REQUIRED.
BASED OFF OF CASE DETAILS, IT WAS DETERMINED THAT THIS WAS NOT A COMPLAINT LINKED TO THE RETURNED DEVICE. THE SERIAL NUMBER RECORDED IS FOR A PHYSICAL CONTROLLER, BUT THE COMPLAINT WAS ABOUT THE SMARTPHONE APP. THE USER PROVIDED THE INCORRECT SERIAL. NO INVESTIGATION IS REQUIRED.
BASED OFF OF CASE DETAILS, IT WAS DETERMINED THAT THIS WAS NOT A COMPLAINT LINKED TO THE RETURNED DEVICE. THE SERIAL NUMBER RECORDED IS FOR A PHYSICAL CONTROLLER, BUT THE COMPLAINT WAS ABOUT THE SMARTPHONE APP. THE USER PROVIDED THE INCORRECT SERIAL. NO INVESTIGATION IS REQUIRED.WE HAD SUBMITTED MULTIPLE SUPPLEMENTAL REPORTS AS THE WRONG DEVICE CAME BACK FOR A SEPERATE ALLEGATION. WE HAVE COVERED THAT IN THE PREVIOUS SUPPLEMENTAL (EMDR-161881) THIS SUPPLEMENTAL IS BEING SENT TO CORRECT THE H3 DROP DOWNS FROM NO TO YES.
THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO NAUSEA, VOMITING, AND DIARRHEA ON (B)(6) 2023. THE PATIENT WAS TREATED WITH IV FLUIDS AND COMPAZINE. THE PATIENT REPORTED THE REASON FOR HER MEDICAL EVENT WAS DUE TO HER OMNIPOD 5 APP NOT BEING COMPATIBLE WITH HER PHONE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. TO IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO NAUSEA, VOMITING, AND DIARRHEA ON (B)(6) 2023. THE PATIENT WAS TREATED WITH IV FLUIDS AND COMPAZINE. THE PATIENT'S MEDICAL EVENT WAS NOT RELATED TO THE DEVICE COMPATIBILITY ISSUE THAT FOLLOWED THREE DAYS LATER.
IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO NAUSEA, VOMITING, AND DIARRHEA ON (B)(6) 2023. THE PATIENT WAS TREATED WITH IV FLUIDS AND COMPAZINE. THE PATIENT REPORTED THE REASON FOR HER MEDICAL EVENT WAS DUE TO HER OMNIPOD 5 APP NOT BEING COMPATIBLE WITH HER PHONE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY.
IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO NAUSEA, VOMITING, AND DIARRHEA ON (B)(6) 2023. THE PATIENT WAS TREATED WITH IV FLUIDS AND COMPAZINE. THE PATIENT'S MEDICAL EVENT WAS NOT RELATED TO THE DEVICE COMPATIBILITY ISSUE THAT FOLLOWED THREE DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 921704 | OMNIPOD 5 APP | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-000559 | PH1K07122211 | 10385081120302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Hospitalization |