Software version 4.11c.Retainer ring black.On 01/11/2022 the customer reported that the device stops in the middle of priming.Inserted a test p-cap into the retainer ring, and it locked in place properly.Device passed displacement, rewind, prime or seating, basic occlusion, force sensor, occlusion, and self tests.No unexpected insulin flow block, no delivery, occlusion alarms or prime or rewind anomalies were noted during testing.Thus software was utilized and uploaded trace or history files properly.The adapt tool does not list any delivery related alerts or alarms that occurred around the event date nor does it list any device errors which could potentially trigger a critical pump error.The case was cut open.After visual inspection, did not note any signs of previous moisture presence or corrosion inside the battery compartment or on any of the boards, assemblies, and the motor inside the device.In summary, the customer¿s report that the device stops in the middle of priming was not confirmed.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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