(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 640g 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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Retainer ring= black.Customer complained on (b)(6) 2022) the insulin pump is over delivering and experiencing low bg.Device passed active current measurement, sleep current measurement test, self test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Device passed delivery accuracy test at (0.08750) inches.No over delivery anomalies noted during testing.Device successfully downloaded to thus.Device successfully downloaded using carelink, however, there is no data available on event date.Unable to verify the amount of devices delivered on event date due to no data present.The electronic assemblies and motor assemblies were inspected and found evidence of moisture damage on electrical board 1, and force sensor pins.The following were noted during visual inspection: scratched case, pillowing keypad overlay, cracked belt clip rails.The p-cap/reservoir does lock properly.No over delivery anomalies noted during testing.Unable to confirm low bgs during 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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