MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-876T SURETPRDGM 2PK 8MM32N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-876T

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 07/20/2017

Event Type  malfunction  

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 reported via phone call that they are experiencing high blood glucose.Customer is reporting that they observed 1/2 inch air bubbles in the infusion set tubing during troubleshooting for the high blood glucose.Customer reports that they had blood glucose of 190 mg/dl in the middle of the night.Customer's blood glucose rose to 246 mg/dl.Customer treated with a bolus after eating food.Customer was able to remove air bubbles through troubleshooting.Customer was advised to change out infusion set.The product is not expected to be returned.

• Brand Name: INFST MMT-876T SURETPRDGM 2PK 8MM32N 21L
• 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: 6983980
• MDR Text Key: 90975138
• Report Number: 2032227-2017-62293
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-876T
• Device Catalogue Number: MMT-876T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 82