MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-941T MIO 2PK 6MM 18IN BLUE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-941T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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's mother reported via phone call that they had experienced a bent infusion set cannula on at least 10 different infusion sets.Customer's mother reported that the bent infusion set cannulas are resulting in impeded delivery of insulin.Customer's mother stated that the bent infusion set cannulas occur almost immediately after insertion.Customer's mother states the blood glucose level begins to rise right away.Customer was able to troubleshoot the bent cannula during the call.Customer did not troubleshoot the elevated blood glucose level.No product is expected to be returned.

• Brand Name: INFST MMT-941T MIO 2PK 6MM 18IN BLUE
• 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: 7175440
• MDR Text Key: 96749390
• Report Number: 2032227-2018-00505
• 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

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-941T
• Device Catalogue Number: MMT-941T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• 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: 8 YR