(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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.
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All operating currents are within specification.Off no power alarm functions properly.The pump passed the displacement test, rewind test, self test and a21 error test.The pump was unable to prime then alarmed a33 at 4.0 lbs during the prime/a33 test, and alarmed motor error during the basic occlusion test due to moisture damage in the fsr.No motor error alarm noted during the rewind test.No e70 alarm noted in the pump's alarm history screen.Unable to perform the occlusion test, excessive no delivery test and the dat due to prime anomaly/a33 alarm and motor error alarm.The following were noted during visual inspection: minor scratched display window, cracked battery tube threads, cracked belt clip slot, cracked reservoir tube, cracked reservoir tube window, missing end cap sticker and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.Please see below when reviewing the history download.There is no data available due to the pump was stored for an extended period without a battery.Unable to verify motor error alarm in the history download file.During visual inspection the motor home switch was corroded.The transducer on the i/b was corroded.Unable to complete the functional testing (occlusion test, excessive no delivery test and the dat) due to prime anomaly/a33 alarm and motor error alarm.Unable to confirm alleged high bg's.Motor error alarm was 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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