MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-923T MIO 2PK 6MM 23IN PINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-923T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 06/25/2016

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they received a high blood glucose level of 439 mg/dl.Customer reported also having issues with no delivery alarms and had found that the infusion set cannulas were bent at the time of these incidents.Customer treated the high blood glucose level with a manual injection of insulin using a syringe.Customer was able to troubleshoot the bent infusion set cannula.Customer declined troubleshooting for the high blood glucose and no delivery alarms, as she believed that were due to the bent infusion set cannula.No product is expected to be returned.

• Brand Name: INFST MMT-923T MIO 2PK 6MM 23IN PINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7175664
• MDR Text Key: 96752735
• Report Number: 2032227-2018-00511
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: MMT-923T
• Device Catalogue Number: MMT-923T
• Device Lot Number: 5135141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 01/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR