MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715K |
Device Problem
No Display/Image (1183)
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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 insulin pump had blank display.Customer stated the display was not blank less than 30 seconds and did not return.Customer stated the contact on the battery cap was not missing or damage or corroded.Customer stated battery compartment was neither damaged nor corroded.Customer stated the spring was neither damaged nor corroded.Customer stated the display did not return after insulin pump restart.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 or reservoir locked properly in place.Device received with cracked reservoir tube lip, cracked retainer, missing display window or cover, cracked keypad overlay, cracked case, cracked case (battery tube), cracked case-corner of belt clip rails, and cracked battery tube threads.Device received with blank display due to pushed in battery tube.Unable to perform displacement test, self test, and current measurements due to display anomaly.
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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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