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Model Number 18320 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Chest Pain (1776); Dehydration (1807); Hyperglycemia (1905)
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Event Date 03/17/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels rose above 24 mmol/l (>432 mg/dl).Symptoms reported include dehydration and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin and calcium.The patient was released the following day.The pod was removed prior to the hospitalization.
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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.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 visited the emergency room (er) due to hyperglycemia.The patient's blood glucose levels rose 24 mmol/l (432 mg/dl).Symptoms reported include dehydration, irregular heartbeat and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin, fluids and calcium utilizing intravenous therapy.The patient was released the same day.The pod was changed prior to leaving for the er.
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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 emergency room visit and 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.Correction to b2 - outcomes attributed to ae from: hospitalization-initial or prolonged to: required intervention correction to b5 - describe event or problem from: it was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels rose above 24 mmol/l (>432 mg/dl).Symptoms reported include dehydration and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin and calcium.The patient was released the following day.The pod was removed prior to the hospitalization.To: it was reported that the patient visited the emergency room (er) due to hyperglycemia.The patient's blood glucose levels rose 24 mmol/l (432 mg/dl).Symptoms reported include dehydration, irregular heartbeat and chest pain.The pod reportedly alarmed while worn on the back for between 5 and 24 hours.The patient was treated with insulin, fluids and calcium utilizing intravenous therapy.The patient was released the same day.The pod was changed prior to leaving for the er.Correction to h6 - adverse event problem health effect - impact code from: f08 hospitalization or prolonged hospitalization to: f12 serious injury/ illness/ impairment correction to h10 - additional mfg narrative from: 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.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.To: 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 emergency room visit and 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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Manufacturer Narrative
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An internal leak on the unexposed portion of the soft cannula was found, causing corrosion on internal components, insufficient battery voltages and preventing recovery of the device data.Without the data, it could not be determined if the device generated an alarm or if the damaged cannula contributes to the reported event.
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Search Alerts/Recalls
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