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Model Number 18320 |
Device Problems
Material Twisted/Bent (2981); Unintended Movement (3026)
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Patient Problem
Hyperglycemia (1905)
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Event Date 12/27/2021 |
Event Type
malfunction
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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.It was reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.We are also 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.Additionally, a pod is paired to a pdm and put through simulated use testing including confirming the blue soft cannula is inspected for any damage.
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Event Description
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It was reported that the patient's blood glucose levels reached 360 mg/dl while wearing the pod longer than 48 hours.Patient stated the cannula dislodged from the infusion site (leg); upon removal, the cannula also appeared bent.As treatment, correction boluses were delivered.
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Manufacturer Narrative
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The received device had the cannula assembly fully deployed.The soft cannula measured the correct full length according to specification and did not appear damaged.Inspection of the fluid path and needle mechanism components found no evidence of any damage or manufacturing deficiencies that would result in the soft cannula becoming dislodged from the infusion site.A root cause for the reported dislodged cannula could not be determined.The received device had the cannula assembly fully deployed.Inspection of the soft cannula did not find it bent, kinked, or damaged.The download data from the pod contained no timeouts, drive stalls, or hazard alarms, indicating that there was no struggle to deliver insulin.The investigation found no evidence of any damage or manufacturing deficiencies that would result in fluid failing to flow through the complete fluid path.
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Search Alerts/Recalls
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