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Model Number MMT-105NNGYNA |
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 03/03/2023 |
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.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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 inpen had not paired to the mobile device app.No harm requiring medical intervention was reported.Troubleshooting was performed, and the issue could not be resolved.The customer will continue to use on receipt and replacement of the device and it will be returned for analysis.
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Manufacturer Narrative
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A complete analysis and testing of the inpen showed, that per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.The leadscrew was received, 1/4 it's travel.Several attempts were made to pair inpen, every time app displayed ¿inpen not found¿.The inpen does not pair with commercial mobile app.Inpen did not transmit to manufacturing app.Inpen passed front cap investigation.Pending further analysis, that will be performed at san diego location.In conclusion: per san diego analysis: inpen failed base line functionality test and passed displacement dose accuracy.Battery measured 0.67v.Inpen will not transmit, due to a dead battery no signs of fluid intrusion.Therefore, the customer concern of inpen not paring to app was confirmed.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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