The customer reported via phone call that they were emergency room visit and hospitalized due to high blood glucose on (b)(6), 2022.The customer¿s blood glucose level was 503 mg/dl at the time of incident.The another blood glucose value was 173mg/dl , 400 mg/dl, 380 mg/dl.The customer experienced symptom such as increased thirst due to high blood glucose value.The customer treated high blood glucose with manual injection.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The auto mode feature was inactive at time of event.Troubleshooting was performed however, the customer will discontinue use of the device.
|