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
Excess Flow or Over-Infusion (1311)
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Patient Problems
Stroke/CVA (1770); Hypoglycemia (1912)
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Event Date 07/20/2020 |
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 customer was hospitalized on (b)(6) 2020 due to low blood glucose level of 28 mg/dl.The customer had stroke on (b)(6) 2020 and was already at the hospital.The customer treated low with glucose tablet and current blood glucose level is 186 mg/dl.The customer stated that insulin pump over delivered units of insulin which led up to event.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the delivery accuracy test at 0.08730 inches.No over delivery anomaly or under delivery anomaly noted.Device uploaded properly using carelink.Device had scratched case, cracked battery tube threads, cracked case at the battery tube side, pillowing keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).
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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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