MEDTRONIC MINIMED INFST MMT-866T SURETPRDGM 2PK 6MM32N 21L; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Model Number MMT-866T |
Device Problem
Bent (1059)
|
Patient Problem
Hyperglycemia (1905)
|
Event Date 12/12/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 2017.Subsequently, medtronic diabetes conducted a two year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.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
|
Customer reported via phone call that he had received a series of high blood glucose events.Customer reported that his blood glucose rose from 270 mg/dl to 560 mg/dl.Customer was able to troubleshoot.Upon removal of the infusion set, customer reported that the infusion set cannula was bent.Customer reported that the infusion set had been in use for three days.Upon removal, customer found black and blue spots at the insertion site.The product is expected to be returned.
|
|
Search Alerts/Recalls
|
|
|