(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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Pump received unable to perform functional testing including the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test due to detached end cap.Pump history download using thds was successful.High bg confirmed was shown on down load report was on (b)(6) 2022 02:10:18 sensor alarm #101 - alrm_high_bg - measured bg value exceeds high glucose limit.The following were noted during visual inspection: loose/protruded drive support disk.Cracked case at the display window corners, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and broken reservoir tube lip.The test p-cap/reservoir does lock into place.Unit received with detached end cap, unable to perform any testing.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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