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Model Number MMT-105ELBLNA |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 12/23/2020 |
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 as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Information received by medtronic through the patient's health care provider indicated the insulin pen user was hospitalized for an issue with the insulin pen not delivering insulin.Blood glucose reading was unknown.No further hospitalization information has been provided.It is unknown if the insulin pen will be returned for analysis.
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Event Description
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Information received by medtronic indicated the insulin pen user was hospitalized for high blood glucose and diabetic ketoacidosis.Blood glucose reading was over 600 mg/dl.The customer was hospitalized on (b)(6) 2020 and was hospitalized for 3 days.While hospitalized, the customer was treated with intravenous insulin drip.It was reported that the insulin pen leadscrew would not depress when pushed and would not dispense insulin.The insulin pen will be returned for analysis.
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Manufacturer Narrative
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Additional information has been received which was not included with the initial report.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 initial report had the incorrect event date.The correct event date is (b)(6) 2020.
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Manufacturer Narrative
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Serial number: n/a.Software version: n/a.Color: blue.Battery life remaining: n/a.The injection screw was not bent.There is a great amount of resistance when the injection screw is being extended or retracted.Removed the injection button and found a considerable number of dust/debris located inside of the inpen.Unable to perform functional test due to this issue.No cosmetic damage was observed.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 have not 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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Manufacturer Narrative
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The injection screw was not bent.There is a great amount of resistance when the injection screw is being extended or retracted.Removed the injection button and found a considerable amount of dust/debris located inside of the inpen.Unable to perform functional test due to this issue.No cosmetic damage was observed.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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