MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
|
Back to Search Results |
|
Model Number MMT-1712KL |
Device Problem
Visual Prompts will not Clear (2281)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/18/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.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 insulin pump involved in this event is the ngp 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.
|
|
Event Description
|
Information received by medtronic indicated that customer stated that pump did not going on.No harm requiring medical intervention was reported.The troubleshooting was performed and it was found that frozen display recurred. it was unknown if the customer had continued to use the device.The insulin pump will be returned for the product analysis.
|
|
Manufacturer Narrative
|
Customer returned pump for alleged frozen screen found on 18-dec-2022.Pump booted up once installing an aa lithium battery, no frozen screen was noted.The pump passed the displacement test, active current test, and self test.The pump failed the sleep current test.Test p-cap locked properly into the reservoir compartment.Pump was cut open to perform visual inspection and found moisture damage on pcba 1, pcba 2, and force sensor.The following were also noted during visual inspection: scratched case, pillowing keypad overlay, cracked keypad overlay, stained keypad overlay, serial number label missing, corroded battery tube, and corroded battery tube spring.Frozen screen was not confirmed during testing.Moisture damage was confirmed found in the battery tube, and on the electronic assembly, and force sensor.High sleep current measurement was confirmed due to moisture damage on the electronic assembly, and force sensor.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
|
|
|