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

Model Number MMT-397T

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

Patient Problem Hyperglycemia (1905)

Event Date 09/20/2017

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

The customer reported via phone call that they experienced a high blood glucose level of 489 mg/dl.The customer reported having a no delivery alarm.The customer declined to troubleshoot for high readings.Troubleshooting was performed for the no delivery alarm.Customer reported that only one drop of insulin exited while performing a fixed prime.Customer removed the infusion set and observed that it had a bent cannula.Customer reconnected the tubing at the quick release.Customer ran an additional fixed prime and observed that very little insulin exited.The product will not be returned for analysis.

• 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: 6977337
• MDR Text Key: 90788503
• Report Number: 2032227-2017-61478
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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: 5171647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• 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: 70 YR
• Patient Weight: 58