Retainer ring = clear on (b)(6) 2021 the customer alleged was hospitalized for high and low blood glucose.The test p-cap locks properly in place in the reservoir compartment noted.The insulin pump received with pillowing keypad overlay and serial number label sticker during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.The insulin pump passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08710 inches.The insulin pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured (22.1 milli volts).The motor was tested outside of the device on the ngp stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer alleged for high and low blood glucose.The force sensor is within specification and the motor functioning properly.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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