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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hypoglycemia (1912); Dizziness (2194)
|
Event Date 06/28/2022 |
Event Type
Injury
|
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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
|
Customer reported via phone call that they hospitalized due to experienced low blood glucose level on (b)(6) 2022.Customer's blood glucose value was 53 mg/dl at the time of the incident.Another blood glucose level was 56 mg/dl.The customer was assisted with troubleshooting for low blood glucose.The customer stated that the symptoms related to low blood glucose such as nausea.The customer was treated with intravenous glucose.It was unknown using insulin pump system within 48 hours of reported low blood glucose event.It was unknown the auto mode feature was active or not at time of low blood glucose event.The device will not be returned for analysis.
|
|
Event Description
|
Customer reported that they had inserted set and reservoir without rewinding the insulin pump and delivered insulin.So, the customer had to go to the emergency room on (b)(6) 2022 for low blood glucose of 53 mg/dl.Customer felt dizzy and did not mention nausea.Customer was treated with intravenous glucose.Insulin pump was used at the time of the incident.It was unknown if sensor was used.Insulin pump does not have auto mode feature.
|
|
Manufacturer Narrative
|
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Initial report was submitted with missing information.The corrected information has been updated and provided with this report in section b5.Health effect clinical code has been updated and provided with this report in section h6.Health effect impact code has been updated and provided with this report in section h6.
|
|
Search Alerts/Recalls
|
|
|