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Model Number 19191 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Death (1802); Hyperglycemia (1905)
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Event Date 08/04/2020 |
Event Type
Death
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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 death 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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(b)(6), a nurse from (b)(6) hospital called to reported that a patient who is on the omnipod system had passed away on (b)(6) 2020.The last known blood glucose reading was noted at 20.4 mmol/l (367.6 mg/dl) on (b)(6) 2020.There was no further information to the patient's cause of the death.
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Manufacturer Narrative
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Device received for investigation on 28sep2020.Device was never unpaired from pod before being returned.Pod l45388 (b)(4) returned with the device.Returned pod was downloaded, no issues noted in device data.An 0x1c alarm occurred during the run indicating the device ran until the 80-hour expiration time.Data downloaded from the device indicates a check pod alarm occurred on the date of the medical event at 21:47:44.This indicates the omnipod personal diabetes manager (pdm) is issuing a status check signal to the pod with no reply.Based on the strip simulation tester, blood glucose readings were found to be within specification and record successfully into the device memory.During the bg meter strip insertion verification test, the pdm recognized the activities and registered readings immediately.No pdm errors were seen in the data on the occurrence date or the day the pdm was last used.A new pod was paired with the pdm.Bolus delivery was tested and a 5u bolus was delivered.No issues were noted during insulin delivery.No issues seen with pod data.Pod successfully communicated with pdm at 5¿ distance, administering 1u bolus.Correction to d(4): sequence number changed from unavailable to (b)(4).Unique identifier (udi) # changed from (b)(4) to (b)(4).
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Search Alerts/Recalls
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