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Model Number 19191 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Dizziness (2194); Diabetic Ketoacidosis (2364)
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Event Date 12/08/2020 |
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 by the patient's mother that a patient had been hospitalized with diabetic ketoacidosis (dka).It was reported that the patient's blood glucose levels reached high, over 500 mg/dl while wearing the pod between 4 and 24 hours.Patient also had high ketones, vomiting, nausea, light headed and dizziness.Patient was taken to the emergency room where they were treated with intravenous therapy with insulin drip and fluids.The nurse told the patients mother that the cannula was kinked.
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Manufacturer Narrative
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No damages were observed with the exposed portion of the soft cannula during investigation.Fluid was observed passing through the fluid path successfully and exiting through the distal tip of the soft cannula.The data downloaded from the device did not show any timeouts or drive stalls during the run.The adhesive pad weld was observed to be misaligned.
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Search Alerts/Recalls
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