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Model Number 18320 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Respiratory Failure (2484)
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Event Date 09/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 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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Event Description
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It was reported that the patient was taken to the emergency room (er) by ambulance and was diagnosed with diabetic ketoacidosis.The patient's blood glucose (bg) values reached 560 mg/dl.The patient had a high heart rate and had trouble breathing.For treatment, the patient was given saline and insulin.The pod was worn between 4 and 24 hours on the abdomen.The patient was discharged after 6 hours.
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Manufacturer Narrative
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A leak was found in the unexposed portion of the soft cannula.This leak caused corrosion, depleted batteries, and a loss of data.This leak and tear to the unexposed portion of the soft cannula directed the fluid away from its intended path, causing an insulin delivery failure.The soft cannula was also found to be damaged in the exposed portion.It was found to be both kinked and stretched.It could be determined when or how this damage occurred.
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Search Alerts/Recalls
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