Model Number MMT-6122 |
Device Problems
Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2024 |
Event Type
malfunction
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Event Description
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It was reported to medtronic minimed that the customer experienced issue with carelink login.The customer reported no adverse event.The event involved product(s) mmt-6122.Unable to complete troubleshooting or provide instructions, insufficient information to escalate.No harm requiring medical intervention was reported.No product return is required for mmt-6122.
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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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As per the information reported by the customer login issue.The rfr sw66 login issue is not a reportable scenario.Hence as per the reportability decision tree the case was not reportable and not required for reporting.Initial regulatory report has been submitted in error.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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