MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715KR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); Muscle Weakness (1967); Pain (1994); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)
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Event Date 10/05/2021 |
Event Type
Injury
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Event Description
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The customer reported via phone call that they were dispatched to emergency medical services on (b)(6) 2021 due to high blood glucose.Customer's blood glucose was 91 mg/dl.Customer treated high blood glucose with insulin pump.Customer stated symptoms related to high blood glucose that were confusion, feeling sick, tired, extremity cramps, pain, unwell, breathing difficulties.Customer had been suffering from sore legs.Customer was using the insulin pump system within 48 hours of reported high blood glucose event.Customer did not test positive for ketones.No further patient complications were reported.Troubleshooting was performed.The device will not be returned for the analysis.
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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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Manufacturer Narrative
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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.The type of investigation, investigation findings and investigation conclusion codes that were provided with the initial report were incomplete.The complete information has been included with this report.The information that provided with the initial report was incorrect.The correct information has been included with this report.
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Event Description
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The device will be returned for analysis.
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Manufacturer Narrative
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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.Information has been corrected which was not correct in the initial report.The information has been provided in section b5 and h6- health effect clinical code with this report.
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Event Description
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Customer was in intensive care unit.
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Search Alerts/Recalls
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