|
Model Number MMT-105NNBLNA |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/27/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Information received by medtronic indicated that the insulin pen had screw movement issue.Customer stated that insulin pen screw had moment issue.No harm requiring medical intervention was reported.The device will be returned for analysis.
|
|
Manufacturer Narrative
|
Serial number: n/a.Software version: n/a.Color: blue.Battery life remaining: n/a.Customer reports: inpen dial locked up, leadscrew movement issues.Per visual inspection: no cosmetic damage noted.Several attempts were made to pair inpen, every time app displayed dose doesn't match and inpen not found.The inpen does not pair with commercial mobile app.The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted.In conclusion: the customer complaint of hard to turn the dial of inpen, hard to dial, hard to push to give insulin was confirmed.Pending further analysis that will be perform in san diego location.Destructive testing showed that leadscrew anomaly was caused by a pattern wheel misalignment due to an encoder base bond failure.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.
|
|
Manufacturer Narrative
|
Serial number: n/a.Software version: n/a.Color: blue.Battery life remaining: n/a.Customer reports: inpen dial locked up, leadscrew movement issues.Per visual inspection: no cosmetic damage noted.Several attempts were made to pair inpen, every time app displayed dose doesn't match and inpen not found.The inpen does not pair with commercial mobile app.The inpen screw retracts when dialing and advances when turning dose knob and high resistance while dispensing and dialing noted.In conclusion: the customer complaint of hard to turn the dial of inpen, hard to dial, hard to push to give insulin was confirmed.Pending further analysis that will be perform in san diego location.Per neta glaser, destructive testing showed that leadscrew anomaly was caused by a pattern wheel misalignment due to an encoder base bond failure.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.
|
|
Search Alerts/Recalls
|
|
|