Model Number MMT-105ELGYNA |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.
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Event Description
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The customer reported via phone call that the insulin pen suddenly stopped injecting insulin.Customer replaced the needles, but the issue was not resolved.Customer stated the screw does not move when they push the dose button.No harm requiring medical intervention was reported.The insulin pen will not be returned for analysis.
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Search Alerts/Recalls
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