MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
|
Back to Search Results |
|
Model Number MMT-1715KL |
Device Problem
Priming Problem (4040)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/08/2022 |
Event Type
malfunction
|
Event Description
|
Information received by medtronic indicated that the insulin pump had a insulin squirting out and continue drip after motor stopped during filling process.No harm requiring medical intervention was reported.The customer will discontinue to use the device.
|
|
Manufacturer Narrative
|
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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.
|
|
Manufacturer Narrative
|
Customer returned device for an alleged prime/fill anomaly on (b)(6) 2022.Test p-cap and reservoir locked properly into reservoir compartment during testing.The device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, self test and occlusion test.The device primed and seated properly when the test reservoir was detected.No prime/fill anomaly noted.Successfully downloaded history files and traces using thus software.Device was cut open to perform visual inspection and found evidence of moisture damage on the electrical board 1 and battery tube assembly noted.The following were noted during visual inspection: scratched case and cracked case (battery tube).In summary, customer alleged prime/fill anomaly not confirmed.Exposed to moisture confirmed.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
|
|
|