The pump passed the displacement test, the rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, and self test.The pump passed displacement accuracy test at 0.0872 inches.Test p-cap and reservoir locks properly into the reservoir compartment.No unexpected alerts, alarms, or anomalies noted during testing.Pump's history and trace files downloaded successfully using thus software and carelink and generated reports.In the pump history and trace files found bolus deliveries on the event date of (b)(6) 2022 at 08:20:00.000, 12:44:00.000, 17:22:00.000, 17:39:46.000, 19:50:22.000, 20:42:04.000, and 22:07:28.000.No alerts, alarms, or anomalies were found in the pump history files and traces on the event date.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, and force sensor.The following were noted during visual inspection: scratched case, and pillowing keypad overlay.Possible over delivery anomaly was not confirmed during testing.Unable to verify customer's complaint for low bg's.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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