(b)(4).Customer returned pump for alleged failed battery test found on (b)(6) 2021.Pump passed displacement test, self test, active current measurement and sleep current measurement.Pump successfully downloaded to thus.Test p-cap successfully locked into the reservoir tube.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No unexpected pump error , low battery alert, power loss alarm, replace battery alert, or replace battery now alarm noted during testing or in the pump trace download.The pump was cut open and the electronic assembly, battery cap and battery tube were inspected and no anomalies noted.The following were noted during visual inspection: pillowing keypad overlay, scratched case, cracked retainer and minor scratches on lcd window.In summary, customers alleged failed battery test was not confirmed during testing.No alarms or battery anomalies were found in the pump history file on/around the event date.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.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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