Customer reported via phone call that they were dispatched in medical services and admitted in emergency room on (b)(6) 2022 due to high blood glucose and diabetic ketoacidosis.Customer blood glucose was over 700 mg/dl.Customer was treated with insulin drip for high blood glucose.Customer current blood glucose was 203 mg/dl.Customer stated symptoms related to high blood glucose that were confusion, tiredness, vomiting and unable to walk.Customer was using insulin pump within 48 hours at the time of event.The insulin pump will be returned for the analysis.
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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 information related to event has been updated in summary and provided in b5 section of this report.
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Retainer ring = clear customer returned pump for an alleged visit to emergency room, ems dispatched and was hospitalized for high bgs and dka found on (b)(6) 2022.Also on case-(b)(4) svn#: (b)(6) & case-(b)(4), svn: (b)(6)- customer returned pump for an alleged visit to emergency room, ems dispatched and was hospitalized for high bgs and dka found on (b)(6) 2022.The pump passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and dat at 0.08665 inches.The pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.The test p-cap and reservoir locked properly into reservoir compartment.However, a cracked retainer¿was noted during testing.The following were also noted during visual inspection: a pillowing keypad overlay, a cracked battery tube thread and a scratched case.A cracked retainer was confirmed.The pump passed all the required testing.Unable to verify customer alleged for high bgs and dka.(b)(4).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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