This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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The pump passed the displacement test, active current test, sleep current test and self test.No blank display noted during testing.Successfully downloaded history files and traces using thus.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No alarms or alerts noted during testing, however, low battery alert on (b)(6) 2024 16:56:00.000 was found in the history files.Pump was cut open to perform visual inspection and found moisture damage on the pcba 1, force sensor and motor home switch.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: corroded battery tube, battery tube threads - cracked, cracked case, scratched case, cracked keypad overlay, stained keypad overlay, cracked case (battery tube) and pillowing keypad overlay.Blank display was not observed during analysis and passed all required testing.Blank display was not confirmed.Frozen screen was not confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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