This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Retainer ring = black.On 03/04/2022, the customer alleged no delivery/occlusion alarms, back light anomaly, charge/battery lasts less than expected, failed battery test alarm, prime/fill anomaly, and rewind anomaly.No backlight anomaly was noted during testing.Pump passed the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, sleep current measurement, active current measurement, and occlusion test.No unexpected insulin flow blocked, failed battery test, prime/fill anomaly, nor rewind anomaly alarms noted during testing.Pump successfully downloaded to thus.No confirmed no delivery, failed battery test, prime/fill anomaly, nor rewind anomaly alarms in the pump downloaded history.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.In further full review in the pump history, no battery related alarms were found on the event date of 03/04/2022.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.Force sensor zero offset within specification (22.5mv).Motor was taken to the test bench where it rewound with no errors or alarms noted.The following were noted during visual inspection: cracked case above arrow and battery icon and pillowing keypad overlay.In summary, pump passed required testing.Customer alleged for no delivery/occlusion was not confirmed.Customer alleged for rewind anomaly was not confirmed.Customer alleged for prime/fill anomaly was not confirmed.Customer alleged for charge/battery lasts less than expected was not confirmed.Customer alleged for failed battery test alarm was not confirmed.Customer alleged for backlight anomaly was not confirmed.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.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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