MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715KR |
Device Problem
Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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.
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Event Description
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Information received by medtronic indicated that the insulin pump had a critical pump error alarm, open book image.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device p-cap / reservoir locked properly in place.Device received with missing display window/cover, cracked retainer, cracked case,cracked case-corner of belt clip rails, and cracked battery tube threads.Unit received with critical pump error due to moisture damage to force sensor.Device received with corroded electronic assemblies and corroded motor home switch.Device unable to perform displacement test, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test due to critical pump error alarm.
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Manufacturer Narrative
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This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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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