MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM SILHOUETTE MMT-382T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-382T

Device Problem Detachment Of Device Component (1104)

Patient Problem Hyperglycemia (1905)

Event Date 10/31/2017

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 they experienced an infusion set tubing detachment.Customer was able to troubleshoot.Customer states that the location of the detachment is the connector cap.Customer reports that the detachment occurred during the infusion set change.Customer reported that they begin to receive bubbles on the second day of use of an infusion set.Customer's blood glucose was 192 mg/dl.Customer treated the elevated blood glucose with the pump.The product is expected to be returned.

• Brand Name: PARADIGM SILHOUETTE MMT-382T
• 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: 7014370
• MDR Text Key: 92072217
• Report Number: 2032227-2017-64850
• 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: 11/09/2017

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-382T
• Device Catalogue Number: MMT-382T
• Device Lot Number: 5193505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/09/2017
• 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: 71 YR
• Patient Weight: 46