MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM POLYFIN; FPA

Model Number MMT-312S

Device Problems Difficult to Remove (1528); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 11/13/2013

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

The customer reported via phone call that they received a no delivery alarm and motor error alarm.The customer's blood glucose was 317 mg/dl at the time of incident.The customer stated that they corrected the blood glucose with manual injection.The customer performed fixed prime and the insulin did exit.The customer stated that they were unable to remove the set at the time of call.The infusion set will not be returned for analysis.

• Brand Name: PARADIGM POLYFIN
• Type of Device: FPA
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5665060
• MDR Text Key: 45513989
• Report Number: 2032227-2016-11349
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K031917
• 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: 11/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-312S
• Device Catalogue Number: MMT-312S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 45 YR
• Patient Weight: 113