MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-921T MIO 2PK 6MM 18IN PINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-921T

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that they experienced an infusion set tubing detachment.The location of the detachment is the needle in the cannula.Customer reported that the needles on their infusion sets are always bent.Customer reported that there was no stress placed on the tubing prior to the detachment.The customer noticed the reported detachment during a set change.Customer's blood glucose was 152 mg/dl.The product is expected to be returned.

• Brand Name: INFST MMT-921T MIO 2PK 6MM 18IN 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: 6976555
• MDR Text Key: 90853850
• Report Number: 2032227-2017-61400
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-921T
• Device Catalogue Number: MMT-921T
• Device Lot Number: 51881087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• 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 Age: 8 YR
• Patient Weight: 25