Retainer ring = black.Customer returned insulin pump for alleged prime/fill anomaly found on october 06, 2021.Insulin pump passed displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, and self test.No unexpected alarms occurred while testing.Successfully downloaded insulin pump history files and traces using thus.Verified insulin pump alarmed insulin flow block alarm on october 06, 2021 at time 11:49:00.000.Insulin pump was cut open and found no evidence of physical or moisture damage on the electronic assembly.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: broken belt clip rails and pillowing keypad overlay.Insulin pump passed all testing and no unexpected alarms occurred.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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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