(b)(4).Customer alleged the pump having devices test failed.Unit received with all operating currents within spec and passed functional testing including the rewind test, self-test, a21 error test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No unexpected unknown alarm anomaly noted during testing.Pump history download using thds was successful.However, a47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.A47 alarms are due to the pump not having power for a long period of time.Pump was cut and open found no moisture/damage on the electronics, battery connector, battery tube, motor, vibrator, keypad flex tail noted during visual inspection.Unit had cracked battery tube threads, scratched case, stained address/serial number label and stained end cap sticker.The test reservoir locked in place properly and no anomaly noted.Unit passed all required test.Pump having function properly, and devices test failed anomaly was not confirmed.The insulin pump involved in this event is the paradigm real-time veo 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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