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Model Number MMT-105NNPKNA |
Device Problems
Computer Software Problem (1112); Material Too Rigid or Stiff (1544)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
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.The device will be returned for analysis and 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 customer experienced no insulin was dispensed when the injection button was pressed because the screw was not moving as indented.Troubleshooting was performed and found that the screw was pulling back into the inpen while dialing and the customer did not touch or twist the injection or dose button.Also, the intended dose amount and dose amount recorded in the inpen app was not same.No harm requiring medical intervention was reported.The customer will discontinue the use of the inpen and it will be returned for analysis.
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Manufacturer Narrative
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Per visual inspection: no physical damage to cartridge holder.Cartridge holder locks properly in place.Front shell does not lock in place properly.The inpen paired to the commercial app.Inpen passed baseline and wireless functionality.App logbook displayed: 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u, 15u.Inpen passed displacement dose accuracy.Inpen passed dialing alignment using dose knob zero alignment gage.Inpen passed the leadscrew reset torque test is within specification (ccw: 6.01ozf-in).Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.In conclusion: inpen passed all required testing.No anomalies were noted and all functions tested ok.Dose log/report data inaccuracy was not confirmed.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken was confirm during testing.Difficult to dial dose was not 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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