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Model Number 19191 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Nausea (1970)
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Event Date 04/03/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had been admitted into the emergency room due to hyperglycemia on (b)(6) 2023.The patient's blood glucose levels reached 466 mg/dl while wearing the pod between 1 and 4 hours.Symptoms reported include hyperglycemia, ketonuria, nauseous, feeling unwell, and lethargy.The patient was treated with iv fluids and had their lab work done.The patient reported the cannula on the pod was bent.The patient was released the same day.The pod was removed before going to the emergency room.
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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 hyperglycemia.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.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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