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Model Number UNK_CARELINKSOFTWARE |
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 08/17/2023 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the customer reported upload was interrupted by a screen asking customer to exit the app due to a security problem they were trying to get the data after 3 aug with the blue adapter.The customer tried twice, both times without success with the same message.They thought there was an error code, but they don't know because it disappeared.Troubleshooting was performed.Customer was told that, depending on the type of error code, it may be possible to improve the situation by checking whether the hospital's security software or other software is interfering with the uploader's operation, but there was also a possibility that this was due to a problem that had been occurring at carelink since the other day.The conversation ended with the staff saying that they would check with the administrative staff.No harm requiring medical intervention was reported.It was unknown if the customer will continue the use of the device or not.The product will not be returned for analysis.
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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.Select patient information cannot be provided due to regional privacy regulations.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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Event Description
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The reported information doesn't meet the criteria of reporting.Initial report has been submitted in error.
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Manufacturer Narrative
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Additional review of the event shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.
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Search Alerts/Recalls
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