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Model Number 18325 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 04/10/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 270 mg/dl while wearing the pod.Symptoms reported include both vomiting and nausea.Once at the hospital the patient was treated with intravenous fluids consisting of insulin, zofran, reglan, ativan, bactrim, metoclopramide, cipro and dalbavancin.The patient was prescribed bactrim and cipro.The patient was released from the hospital after 7 days.It should be noted the patient has gastroparesis.
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Manufacturer Narrative
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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 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.
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Search Alerts/Recalls
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