MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-864T

Device Problems Bent (1059); Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 had a broken infusion set needle.Customer reported that the infusion set was not working correctly while trying to use it.Customer reported that upon removal of the infusion set, they found the needle broken and bent at a 45 degree angle.Customer is reporting a past event.Customer did not troubleshoot during the call.The customer's blood glucose level at the of the incident and the time of the call are unknown.The product is not expected to be returned.

• Brand Name: INFST MMT-864T SURETPRDGM 2PK 6MM23N 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: 7149254
• MDR Text Key: 95962242
• Report Number: 2032227-2017-77478
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-864T
• Device Catalogue Number: MMT-864T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 64