MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1714K |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Hyperglycemia (1905)
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Event Date 12/21/2020 |
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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It was reported that the customer had high blood glucose level of 22.6 mmol/l.Customer stated that they were not able to remove battery cap.The insulin pump will not be returned for analysis.Frn-unk-rsvr, unomed-unk.
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Manufacturer Narrative
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Device p-cap or reservoir locked properly in place.Device received with missing display window/cover, cracked keypad overlay, cracked case, cracked case, cracked case-corner of belt clip rails, and cracked battery tube threads.Device passed displacement test, self test, rewind, prime or seating, basic occlusion test, force sensor test, occlusion test, active current measurement, and sleep current measurement.No battery or power anomalies noted during testing however, pump error 25 is confirmed in device history files and unexpected battery power loss is shown power graph generated by adapt power management tool due to j6 resistance connector issue.Device received with battery cap contact missing, however device received was properly tested using a test battery cap.
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Manufacturer Narrative
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Updated h9: 2032227-060322-002-c.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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