|
Model Number MMT-105ELBLNA |
Device Problems
Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hyperglycemia (1905)
|
Event Date 12/25/2021 |
Event Type
Injury
|
Event Description
|
Customer reported via phone call that they had experienced high blood glucose levels.Blood glucose level at the time of incident was 500 mg/dl.Customer reported the dose log was not showing the full amount.The intended dose amount and dose amount recorded in the inpen app was greater than 1.0 unit.The inpen will be returned for analysis.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Serial number: (b)(6), software version: 3.8.5, color: blue, battery life remaining: <9 months.Customer reports: dose log inaccuracy and hospitalized due to a high bg's event.Per visual inspection: the alignment of the dose indicator mark and printed values on the dose knob is nominal.No misalignment of the dial was noted.No physical damage to injection foot or inpen was noted.Unit paired successfully to commercial app.My inpen menu displayed: the following test values were dialed and dosed: 10 test values of 4.0u dialed and dosed.All values displayed accurately in the logbook.All doses were written to the app logbook within 1 minute.The screw was not bent, advanced when dosage knob was pressed dialing a dosage and retracted appropriately.No resistance was observed when dosing without a cartridge installed.The screw advanced every time 30.0u was dialed and dosed until the screw reached max extension.In conclusion: inpen received working as design.No malfunctions noted during testing that could affect insulin delivery.The patient complaint of dose log inaccuracies could not be confirmed.Inpen did not produce any false dose logs during investigation.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
|
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.Information has been corrected which was not correct in the initial report.The information has been provided in section b1 and h6 with this report.
|
|
Search Alerts/Recalls
|
|
|