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 Problems
Connection Problem (2900); Patient Device Interaction Problem (4001)
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Patient Problems
Dehydration (1807); Hyperglycemia (1905)
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Event Date 11/03/2020 |
Event Type
Injury
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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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The customer reported via phone call that they were hospitalized due to dehydration with high blood glucose level on unknown date.Customer¿s blood glucose level was 605 mg/dl, at the time of incidence however, at the time of hospitalization it was over 300 mg/dl.Customer reported they had stress.They treated with intravenous fluid for high blood glucose level.Customer reported that they gave bolus to themselves.Customer had been using insulin pump within 48 hours of reported high blood glucose level.Customer reported plastic retainer ring was damaged.Reservoir was unable to lock in place.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device 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 delivery accuracy test at 0.08700 inches.The test p-cap locks properly in place in the reservoir compartment noted.Device received with pillowing keypad overlay and cracked retainer.(b)(4).
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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 information that provided with the initial report was incorrect.The correct information has been included with this report in b5 section.
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Event Description
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The customer reported via phone call that they went to the emergency room on (b)(6) 2020 due to high blood glucose of 300 mg/dl.The customer reported her blood glucose was fluctuating between 519 mg/dl to 578 mg/dl.The customer reported she was also dehydrated and received intravenous fluids.The customer stated that the retainer ring was damaged and that the reservoir did not lock into place.The customer had been using insulin pump system within 48 hours of reported high blood glucose event.The device will be returned for analysis.
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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.Updated h9: z-0955-2020.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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