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.Serial number: n/a, lot number: b1059, software version: n/a, color: pink, battery life remaining: n/a, first bond date: n/a, initial battery %: n/a, last bond date: n/a, last battery %: n/a, user mobile device: samsung a53 android: 13, testing mobile device: iphone 12 and galaxy s21 5g android: 13 and ios: 16.6 customer reports: inpen not pairing to app.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Cartridge holder locks properly in place.The leadscrew was received 1/4 it's travel.Several attempts were made to pair inpen, every time app displayed ¿inpen not found¿.The inpen does not pair with commercial mobile app.Inpen did not transmit to manufacturing app.Performed battery investigation and battery measured 0.26v.Unable to perform baseline wireless functionality or displacement dose accuracy test.Inpen passed front cap investigation.In conclusion: inpen did not transmit doses to app due to depleted battery (0.26v).Therefore, the customer concern if inpen not pairing to app 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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