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Model Number MMT-6112 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2022 |
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.
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Event Description
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Information received by medtronic indicated that the customer was unable to pair insulin pump with other devices such as transmitter, meter, mobile device.Customer also missed many alerts on carelink connect app specially during night.No harm requiring medical intervention was reported.Troubleshooting was unknown.The product will not be returned for analysis.
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Manufacturer Narrative
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Analysis summary: the software is functioning correctly, and no malfunctions have been identified.An attempt to reproduce the reported issue was made on multiple devices, including an iphone 13 (ios 15.1.1) using minimed mobile 1.2.1 and an iphone xs (ios 15.2) with carelink connect 2.2.The issue could not be replicated as all notifications were displayed as expected, indicating that the software is operating properly.A definitive root cause could not be determined without logs, but it is likely related to the iphone's focus mode being enabled or poor connectivity within the household.The helpline was asked to provide some troubleshooting steps for the customer, such as disabling the focus option and removing the carelink connect app from the notification summary.Despite multiple attempts, the customer became unresponsive, and the ticket was marked as closed with no resolution (aa01af).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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