| Model Number MMT-8060 |
| Device Problem
Computer Software Problem (1112)
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| Patient Problem
Insufficient Information (4580)
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| Event Date 08/17/2021 |
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Event Type
malfunction
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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 indicated that the inpen had dose log inaccuracy concern reported by customer dose amount displayed in logbook for dose in question 4.5 12.5 was intended dose amount and dose amount recorded in the inpen app greater than 1.0 unit.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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(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 provided with the initial report in section d1/d2 was incorrect.We have corrected the product code to ndc which has been updated on this report.
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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.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 and follow-up report.The information has been provided in section b5 with this report.
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Event Description
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The device is not expected to return for analysis.
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Event Description
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Information received by medtronic indicated that there was discrepancy between the dose delivered and the dose recorded in the inpen app.Customer also reported that they were having issue getting the cartridge to stay into the device.Customer stated they took a dose of 4 units but the app showed doses of 12.5 units at 12:44, 4.5 units at 12:45 and another 4.5 units at 12:45.Customer indicated the difference between the dose intended and dose logged was always greater than 0.5 units.Customer was assisted with troubleshooting and was instructed to remove the cartridge holder and dispense 5 units 3 times.Customer stated the app recorded 5.0 units each time.Blood glucose was 190 mg/dl at the end of the call.No harm requiring medical intervention was reported.The device is expected to return for analysis.
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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.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 b5 with this report.
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Manufacturer Narrative
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After further investigation of the complaint and app information available, the inpen app properly recorded the intended 4-unit dose delivered from the inpen at 12:24:06 on (b)(6) 2021.The app also recorded priming amounts of 12.5, 4.5, and 4.5 units about 20 minutes after the 4-unit dose was delivered.The three prime values of 12.5, 4.5, and 4.5 occurred during a cartridge replacement event.These values temporarily displayed as a rapid-acting dose on the app and by the time the cartridge replacement was done they displayed as ¿prime¿ on the app.As a result, there is no discrepancy between the dose delivered from the inpen device and the values recorded in the inpen app.A review of the customer¿s inpen app logbook data (figure 1) was performed by accessing the customer¿s app raw data from our system.The raw data was exported into an excel workbook file containing two worksheets.The excel file is attached for reference.The content of each worksheet is described below.Worksheet title data from complaint event date (b)(6) 2021.Logbook tracked changes_aug17 represents a trace of changes within the logbook data that shows the rapid-acting dose (bolus) and prime data in the background before it becomes a final display in the logbook app screen logbook data final_(b)(6) represents the final rapid-acting dose (bolus) and prime data displayed in the logbook app screen.The following logbook data contains the sequence of events that took place which explains why there is no discrepancy between the 4.0 unit intended dose delivered from the inpen and the inpen app logbook as it relates to this report inquiry.Logbook data final _(b)(6) worksheet - this represents the final information that displayed on the inpen logbook app.See figure 1.In row 4 ¿ the intended 4-unit dose was delivered and displayed on the logbook app screen as a rapid-acting dose (bolus type).Time stamp was 12:24:06 per column a.In rows 9, 11, and 12 ¿ 20 minutes later, the 12.5, 4.5, and 4.5 unit values displayed on the logbook app screen as prime starting at 12:44:45 per column a.In rows 14 to 16 ¿ the three 5-unit primes are from troubleshooting with the customer.This is evidence that all three values were displayed on the inpen app¿s logbook screen.Figure 1: logbook data final_(b)(6).Based on our 24-hour technical support (tech support) troubleshooting notes, the customer's inpen and inpen app functioned properly while troubleshooting.The customer was advised to remove the cartridge holder and deliver 5 units from the inpen three times.This is intended to determine whether the logbook will record the dialed dosages accurately.Based on troubleshooting results and the review of logbook app data from our system, all three 5-unit inpen deliveries were accurately recorded in the logbook.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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