The pump passed the self test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, and the displacement test.The pump history and trace files were successfully downloaded using thus.There were no pump error 130 alarms noted during testing.A review of the downloaded history files reveal six (6) pump error 130 alarms (08:32 to 08:57) and five (5) pump error 43 alarms (08:32 to 09:01) that occurred.The pump was cut open to perform visual inspection.Moisture damage was found on the electronic assembly (pcba 1 and pcba 2), motor, and force sensor.Pump error 43 and 130 alarms are not confirmed.No pump error 43 or 130 alarms noted during testing and the alarms in the history file may have been an intermittent failure that was not detected during our testing.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during physical inspection: scratched case and pillowing keypad overlay.Pump error 43 and pump error 130 alarms are not confirmed.No pump error 43 or pump error 130 alarms noted during testing and the pump error 43 and pump error 130 alarms found in the history file may have been an intermittent failure that was not detected during our testing.Moisture damage is 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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