MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN
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Model Number MMT-712EWS |
Device Problems
Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
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Patient Problems
Hyperglycemia (1905); Coma (2417)
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Event Date 02/21/2023 |
Event Type
Death
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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.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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Event Description
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Information received by medtronic indicated that the customer experienced hyperglycemia and reported pump occurred with no delivery alarm on (b)(6) 2023. the hyperglycemia was treated with the insulin pen. the customer had been in a coma 2 times and was hospitalized.The customer passed away on (b)(6) 2023. troubleshooting was performed partially. it was unknown whether the pump was used within 48 hours at the time of the high blood glucose event. the cause of death was unknown. it was unknown whether the customer wore the pump at the time of passing.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Additional information has been received and information submitted in the initial report was corrected.The corrected information has been provided in section b5 and h6 (type of investigation and investigation findings) with this report.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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Event Description
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The device will not be returned for the analysis.
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Search Alerts/Recalls
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