Pump displays battery failed alert as soon as new battery is inserted.Unable to perform displacement test, sleep current test, active current test, and self test.Unable to download history files and traces using thus due to battery failed alert.Pump was cut open to perform visual inspection and found¿no evidence of physical or moisture damage¿on the electronic assembly, motor, or force sensor.Swapping out test boards confirms battery failed alert isolated to pcba 2.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: pillowing keypad overlay.Failed battery alarm isolated to pcba 2.Pump failed to download history files and traces due to defective pcb a2.Blank display not confirmed.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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