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Model Number 14000 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Dizziness (2194); Diabetic Ketoacidosis (2364); Cognitive Changes (2551)
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Event Date 12/18/2022 |
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 had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels read high (>500 mg/dl) while wearing the pod between 4 and 24 hours.Symptoms reported include hyperglycemia, dizziness, weakness and confusion.In addition the patient was unable to walk.Once at the hospital the patients pod was removed and the cannula had been found to be bent.The patient applied a new pod and administered a bolus of 20 units of insulin.The patient had blood work performed and the patients blood glucose level was monitored.The patient was give intravenous fluids as well as insulin.The patient was prescribed ibuprofen (100 mg) and ondansetron (4 mg) to be taken once every 12 hours as needed for nausea.As a result of this event the patient had manual insulin administered the following week.The patient was discharged from the hospital after 2 days.
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Manufacturer Narrative
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The received device had the cannula assembly fully deployed.Inspection of the cannula assembly did not find it bent, kinked, or damaged.The investigation found no evidence of any damage or manufacturing deficiencies that would result in the device failing to deliver insulin.
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Search Alerts/Recalls
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