(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 ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin 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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Unit passed active current measurement, sleep current measurement test, selftest, rewind, seating, basic occlusion test at 4.5 pounds, occlusion test, force sensor test and displacement test.Unit passed dat test at.08730 inches.No under delivery anomalies noted during testing.There were no pump error 130 alarms noted during testing.Unit successfully downloaded to thus and carelink.Pump trace download analysis confirmed the pump alarmed pump error 130 on (b)(6) 2022 12:54:01.000.The electronic assemblies and motor assemblies were inspected and no anomalies noted.The p-cap/reservoir does lock properly.The pump error 130 alarms located in the history files may have been an intermittent failure that was not detected during our testing.The following were noted during visual inspection: scratched case, and pillowing keypad overlay.Pump passed functional testing and no over delivery anomalies noted during testing.Pump error 130 mfda alarms are not confirmed.No pump error 130 alarm was noted during testing and is expected if the pump experienced a strong magnetic field (the pump behaved as expected) and may have been an intermittent failure that was not detected during our testing.Could not confirm customer complaint of error's 37, 38, 41, 42, 43, 79, 80, 82, and they were not found in the pump history.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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