It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose (bg) levels reached over 400 mg/dl while wearing the pod.After delivering a correction and falling asleep, patient awoke to bg levels still high so went to the hospital; she also experienced dizziness and was told she had a mini stroke.The patient self administered manual insulin injections as treatment, but only received diagnostic testing during hospital stay (blood tests, cat scan and an echocardiogram).The patient was released after 3 days/2 nights.The pod was removed prior to the hospital visit and was discarded.
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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 hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.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.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.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.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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