MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1762WWK 670G V4.11 SF MM; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
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Model Number MMT-1762WWK |
Device Problem
Power Problem (3010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2020 |
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 they received critical pump error image on the insulin pump screen.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 was received with a critical pump error (open book image) alarm due to moisture damage on the electronic assembly.Unable to perform the self test, displacement test, rewind test, prime or seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, and active current measurement test due to critical pump error (open book image) alarm.Moisture damage was also found on the motor and force sensor during visual inspection.Device was also received with serial number label missing, partially broken reservoir tube lip, missing retainer, missing reservoir tube o-ring, case cracked behind the device at the corner of the belt clip rails and cracked battery tube threads.A test p-cap and reservoir was installed and did not lock in place due to broken reservoir tube lip and missing retainer.
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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-0956-2020.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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