Model Number ACC-7350 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
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, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Select patient information cannot be provided due to regional privacy regulations.
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Event Description
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Information received by medtronic indicated that the customer has reported the carelink personal uploader issue.Troubleshooting was performed and the issue was not resolved.No harm requiring medical intervention was reported.The customer will continue using the application and the product will not be returned for analysis.
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Manufacturer Narrative
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Complaint summary: user reported inability to complete pump uploads.Investigation/testing summary: no attempt to reproduce was performed, type of issue not reproducible by carelink support team.Carelink support team confirmed through database application logs that there were multiple consistent teneo security certificate errors present in all of the user's recent upload attempts.Confirmed through helpline that pump was not properly configured in teneo system.Advised helpline to replace user's pump to resolve the issue.The software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the 10542712doc_x, version pch00104012.(most likely) root cause: teneo misconfiguration of user's pump.Analysis summary: recommended to helpline that pump should be replaced due to teneo misconfiguration.Helpline confirmed that pump was replaced.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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