Retainer ring = black.Customer returned pump for an alleged blank display and cosmetic damage found on (b)(6) 2022.The pump passed the displacement test, active current test, sleep current test, and self test.No blank display was noted during testing.Successfully downloaded history files and traces using thus.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.The pump was cut open to perform a visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.No alarm and power anomaly was noted.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: broken belt clip rails, cracked keypad overlay , pillowing keypad overlay, label damage (serial number).The blank display was not confirmed.Cosmetic damage was confirmed.(b)(4).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.
|