Model Number MMT-751NAS |
Device Problems
Premature Discharge of Battery (1057); Break (1069); Mechanical Problem (1384); Loss of Data (2903)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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Information received by medtronic indicated that the retainer ring was damaged and the reservoir was able to lock in place.Insulin pump had motor error and customer was able to clear alarm.Customer was able to rewind insulin pump.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
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Event Description
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Information received by medtronic indicated that the retainer ring was damaged and the reservoir was able to lock in place.Insulin pump had motor error and customer was able to clear alarm.Customer was able to rewind insulin pump.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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(b)(4).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.
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Manufacturer Narrative
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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.The information related to event has been updated and provided in b5 section of this report.
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Event Description
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It was reported that the insulin pump had a recurring unexpected restart alarm.Temporary basal was not programmed before the alarm occurred.Customer also received external ram crc error alarm when insulin pump history was checked.Customer stated the device was damaged with scratches, missing piece, scuff marks, hairline crack, half ring broken off by the reservoir window.
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Search Alerts/Recalls
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