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Model Number MMT-105ELGYNA |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Hyperglycemia (1905)
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Event Date 06/01/2022 |
Event Type
Injury
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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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The customer reported via phone call that they were experienced high blood glucose level.Customer¿s blood glucose level was 425 mg/dl at the time of incident.Customer stated that insulin pen screw was not moving as intended.Customer declined troubleshooting for high blood glucose level.No further patient complication were reported.The customer will continue to use the device.
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Manufacturer Narrative
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Per visual inspection: cap no longer stay attached and missing dose window.No physical damage to cartridge holder was noted.The inpen paired to the commercial app with small pairing dose.The screw is not bent.However, the screw retracts into inpen when trying to dial a dose.The leadscrew does not advance when 30.0u are dialed.Unable to perform functional test due to leadscrew anomaly.In conclusion: per dennis berg san diego investigation: debris was lodged in between electronics housing and dose knob.Causing the inpen to retract and extend when the dose knob was turned.This can affect insulin delivery.Therefore, the customer complaint of leadscrew anomaly 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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