On (b)(6), 2021 the customer returned insulin pump for an alleged blank and frozen.Device received with blank display, problem isolated to m/b board.Unable to perform normal operating current.The stop (idle) current and run current measurement tests self test, rewind test and displacement test or verify frozen display due to blank display.The following were noted during visual inspection: cracked belt clip slot and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.No moisture damage found on the electronics, motor, battery tube, keypad and vibrator assembly noted.The original m/b board was removed and replace with a test m/b.No anomalies was notice after battery insert.Problem isolated to m/b.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.
|