According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.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.High blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626.[1] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755.[1] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158.
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It was reported by daughter that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 499 mg/dl while wearing the pod between 36 and 48 hours.Symptoms reported include hyperglycemia, vomiting, lack of ability to communicate, paleness and patient was lethargic.Patient also showed small signs of pneumonia, an internal infection, high white blood cell count and low body temperature.The patient was treated with intravenous insulin, saline, antibiotics and a heparin drip.The patient had been hospitalized 2 days prior and remained in the hospital at the time of reporting.The pod was removed at the hospital and was discarded.
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