MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397T

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 02/10/2018

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.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 received an insulin flow blocked alarm that was resolved by changing her infusion set.The customer's blood glucose level at the time of the incident was 363 mg/dl.Customer declined to troubleshoot at the time of the call.She was reporting a past event.The infusion set is not expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-397T
• 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: 7298275
• MDR Text Key: 101123043
• Report Number: 2032227-2018-01650
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Device Lot Number: 5195720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2018
• 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: 53 YR
• Patient Weight: 68