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 Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912); Vomiting (2144); Chills (2191); Diabetic Ketoacidosis (2364); Ventilator Dependent (2395)
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Event Date 08/01/2019 |
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¿s wife reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis, incoherent, ventilator, shivering on (b)(6) 2019 with blood glucose of 1290 mg/dl.The customer experienced symptoms such as throwing up after feeling unwell.The customer was treated with intravenous injection and intensive care unit.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/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the delivery accuracy test.Device uploaded properly using care link.Battery cap was damaged - broken off heat stake posts causing the battery cap contact to become loose.Device also had minor scratched display window, missing display window cover, scratched case, cracked battery tube threads, cracked case at the corner of the belt clip rail and a pillowing keypad overlay.(b)(4).
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Manufacturer Narrative
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Updated h9: 2032227-060322-002-c.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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