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 Problems
Computer Software Problem (1112); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Power Problem (3010); Priming Problem (4040)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the insulin pump showed no delivery alarms and rewind anomaly.It was also reported that the pump battery test failed, pump rejected new batteries, message came that said that was a block in connector set, pump has erased settings when putting in a new battery, pump buttons were sticky and non responsive, pump has to prime or rewind more than once, prime and rewind process seems to take longer than before.Customer declined to troubleshoot no further patient complications were reported.The device will not be returned.
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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.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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