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 Problems
Mechanical Problem (1384); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Vomiting (2144)
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Event Date 07/05/2020 |
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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It was reported that the customer was experiencing high blood glucose.The customer had high blood glucose levels of 30.0 mmol/l and 33.3 mmol/l at the time of incident which was treated with the syringe.The customer experienced symptoms such as nauseous, vomiting, and blurred vision.The customer was alleging that the insulin pump was under-delivering because the piston was not moving and tried to run insulin and no insulin was running through.The customer had been using insulin pump system within 48 hours of reported high blood glucose event.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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Device passed the displacement test, rewind test, prime or seating test, basic occlusion test, force sensor test, occlusion test, self test and displacement accuracy test.Possible under delivery anomaly not confirmed.(b)(4).
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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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