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Model Number UNK_7311SOLUTIONS |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported to medtronic minimed that the customer experienced a loss of communication of the pump with the meter, transmitter, and mobile device.No further details were provided.The customer reported no adverse event.The event involved product(s) unk_7311solutions.The customer did not have other devices to troubleshoot.No harm requiring medical intervention was reported.No product return is required for unk_7311solutions.
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Search Alerts/Recalls
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