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
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Software version 4.11d.Retainer ring = black.Case type =ngp.Customer returned insulin pump for alleged cosmetic damage located at the battery compartment found on (b)(6) 2022.The insulin pump passed the displacement test and p-cap locks properly into the reservoir compartment.The following were noted during visual inspection: scratched case, battery tube threads cracked, cracked keypad overlay, stained keypad overlay, pillowing keypad overlay, cracked belt clip rails, cracked case (battery tube), keypad overlay texture damage, cracked reservoir tube lip.Cosmetic damage was confirmed at battery compartment.Additional cosmetic damages were noted on the unit.The insulin pump involved in this event is the ngp 640g insulin 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.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.
|
|
Event Description
|
Information received by medtronic indicated that the insulin pump was cracked near battery compartment and the back.Insulin pump was neither bumped nor dropped.Infusion set and reservoir did not show sign of damage.Retainer ring was not damaged.Troubleshooting was performed.No harm requiring medical intervention was reported.The device was returned for analysis.
|
|
Manufacturer Narrative
|
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.Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.
|
|
Event Description
|
Insulin pump was cracked near battery compartment and the back.Insulin pump was neither bumped nor dropped.Infusion set and reservoir did not show sign of damage.Retainer ring was not damaged.In failure analysis note they mention the pump passed the displacement test and p-cap locks properly into the reservoir compartment.The following were noted during visual inspection: scratched case, battery tube threads cracked, cracked keypad overlay, stained keypad overlay, pillowing keypad overlay, cracked belt clip rails, cracked case (battery tube), keypad overlay texture damage, cracked reservoir tube lip.Cosmetic damage was confirmed at battery compartment.According to job aid crack was not reportable on insulin pump.
|
|
Search Alerts/Recalls
|
|
|