MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-399T

Device Problems Bent (1059); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

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 her daughter received an insulin flow blocked alarm.The alarm occurred upon insertion of a new infusion set.Upon removal, customer noticed that the cannula was bent.Customer stated that her daughter's blood glucose level was high at the time of the incident, but she did not specify a blood glucose value.Customer declined troubleshooting for the high blood glucose value, the insulin flow blocked alarm, and the bent infusion set cannula.Blood glucose value is unknown.The infusion set is expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-399T
• 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: 7063699
• MDR Text Key: 93583551
• Report Number: 2032227-2017-68455
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/28/2017

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: Patient Family Member or Friend
• Device Model Number: MMT-399T
• Device Catalogue Number: MMT-399T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 11/28/2017
• 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: 7 YR
• Patient Weight: 29