Unable to perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, active current measurement test, self-test or verify critical pump error (open book image) alarm due to blank display.Moisture damage was also found on the force sensor, 40 pin flexible printed circuit/lcd, electronics stack pcba1, pcba2, and motor during visual inspection.Unable to download firmware using crest due to display anomaly.Pcba1 and pcba 2 was swapped out with a working test board and successfully powered up confirming blank display is due to moisture damage on pcba 1 and pcba2.The following were noted during visual inspection, cracked battery tube threads, fading serial number label, cracked keypad overlay at select button, and cracked case corner of belt clip rails.The unit p-cap / test reservoir locks in place properly.Critical pump error (open book image) alarm unknown due to blank display.Blank display due to moisture damage on pcba1 and pcba 2.Unable to download history files and traces due to blank display.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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