MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
|
Back to Search Results |
|
Model Number MMT-1715K |
Device Problems
Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
|
Patient Problems
Hematoma (1884); Hyperglycemia (1905)
|
Event Date 04/07/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The customer reported via phone call that the customer experienced hyperglycemia and insulin flow blocked.The customer blood glucose level was over 600 mg/dl, 272 mg/dl, 300 mg/dl, 188 mg/dl and 107 mg/dl.Customer states the insulin did not exit and insulin pump alarmed insulin flow blocked.Customer states the cannula was not bent.The customer also reported the insulin pump was under delivering.The insulin pump will be returned for analysis.
|
|
Manufacturer Narrative
|
(b)(4).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 dat at 0.08680 inches.No unexpected insulin flow blocked alarm noted.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|