MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-965T MIO 2PK 6MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-965T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 06/04/2017

Event Type  Injury  

Manufacturer Narrative

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 reported via phone call that they were experiencing a high blood glucose level and observed an infusion set with a bent cannula.The customer was assisted with troubleshooting for bent cannula.It was explained to customer the proper preparation process and insertion techniques.The customer's blood glucose at the time of the incident was 468 mg/dl/.Customer treated with manual injection.Customer declined troubleshooting for high blood glucose readings.Customer reports that the high blood glucose and bent cannula were observed less than 12 hours into using the infusion set.Customer was advised the infusion set will be replaced.The product was not returned.

• Brand Name: INFST MMT-965T MIO 2PK 6MM 32IN CLEAR
• 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: 6978158
• MDR Text Key: 90280074
• Report Number: 2032227-2017-61560
• 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
• Type of Report: Initial
• Report Date: 10/25/2017

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 Model Number: MMT-965T
• Device Catalogue Number: MMT-965T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2017
• Initial Date FDA Received: 10/25/2017
• 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: 50 YR
• Patient Weight: 75