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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hyperglycemia (1905); Vomiting (2144)
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Event Date 07/14/2021 |
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.
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Event Description
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It was reported that the customer passed away in hospital on (b)(6) 2021.The customer was hospitalized on (b)(6) 2021 due to blood glucose was gone up to 700 mg/dl and customer was vomiting, caller stated that the hospital rushed him to intensive care unit.The cause of death was high blood glucose, atrial fibrillation and a stroke.The caller stated that the customer had 3 incidents of high blood glucose events that may have led to the customer's passing.The customer¿s blood glucose was normal mg/dl at the time of death.Hospital staff took off the insulin pump because they did not know how to work it and was going to treat the customer manually.The customer was not wearing the insulin pump at the time of death.The customer was using sensors.The insulin pump had been disconnected on (b)(6) 2021.The caller agreed to return the insulin pump for analysis.
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Manufacturer Narrative
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Retainer ring = clear.On (b)(6) 2021 the customer passed away.Device passed the functional test, 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 the delivery accuracy test at 0.0874 inches.The following were noted during visual inspection: minor scratched display window, scratched case, cracked battery tube threads, cracked case at the battery tube side, scratched keypad overlay, pillowing keypad overlay, cracked keypad overlay at the select button, cracked retainer and corroded battery tube.The test p-cap and reservoir does lock in place in the reservoir compartment.Device did not have a battery installed when received.History download was successful using thus and carelink upload was successful.Please see below for the customer's daily total of all insulin delivered surrounding the event date (b)(6) 2021 listed on smartsolve and the days prior to the event date.(b)(6) 2021 dailytotalofallinsulindelivered = 29.6, (b)(6) 2021 dailytotalofallinsulindelivered = 31.5, (b)(6) 2021 dailytotalofallinsulindelivered = 31.6, (b)(6) 2021 dailytotalofallinsulindelivered = 30.2, (b)(6) 2021 dailytotalofallinsulindelivered = 25, (b)(6) 2021 dailytotalofallinsulindelivered = 22.925, (b)(6) 2021 dailytotalofallinsulindelivered = 0.There was no data listed after (b)(6) 2021.Device passed the functional testing.However, during visual inspection the pump had a corroded battery tube.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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Manufacturer Narrative
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Updated analysis summary by (b)(6) on march 17, 2022.Retainer ring = clear.On (b)(6) 2021, the customer passed away.Device was returned with no allegation.Device passed the functional test, 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 the delivery accuracy test at 0.0874 inches.The following were noted during visual inspection: minor scratched display window, scratched case, cracked battery tube threads, cracked case at the battery tube side, scratched keypad overlay, pillowing keypad overlay, cracked keypad overlay at the select button, cracked retainer and corroded battery tube.The test p-cap and reservoir does lock in place in the reservoir compartment.Device did not have a battery installed when received.History download was successful using thus and carelink upload was successful.Please see below for the customer's daily total of all insulin delivered surrounding the event date (b)(6) 2021, listed on smartsolve and the days prior to the event date.(b)(6) 2021 daily total of all insulin delivered = 29.6.(b)(6) 2021 daily total of all insulin delivered = 31.5.(b)(6) 2021 daily total of all insulin delivered = 31.6.(b)(6) 2021 daily total of all insulin delivered = 30.2.(b)(6) 2021 daily total of all insulin delivered = 25.(b)(6) 2021 daily total of all insulin delivered = 22.925.(b)(6) 2021 daily total of all insulin delivered = 0.There was no data listed after (b)(6) 2021.Device passed the functional testing.Device was returned with no allegation.However, during visual inspection the pump had a corroded battery tube.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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Manufacturer Narrative
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This report is part of a retrospective review and remediation efforts in response to a warning letter.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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