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

Model Number MMT-397T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 05/23/2016

Event Type  Injury  

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 experienced a high blood glucose level of 33 mmol/l.Customer treated the elevated blood glucose level with a manual injection of insulin.Customer reported removing four separate infusion sets and finding that they all had infusion set cannulas that were bent.Customer believes that the high blood glucose level was due to the bent infusion set cannulas.Customer was able to troubleshoot the bent infusion set cannula during the call.Customer declined troubleshooting for the high blood glucose level as they believed it was attributable to the bent infusion set cannula.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: 7208258
• MDR Text Key: 97849692
• Report Number: 2032227-2018-00869
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Device Lot Number: 5032914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other