MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723RNAS

Device Problems Sticking (1597); Malposition of Device (2616); Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2016

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

The customer reported via phone call that he was changing the infusion set and the insulin pump was rewound.Customer stated that the drive support cap is pushed out and the pump was reading no reservoir.Customer stated that the drive support cap is sticking out at the back of the motor.Customer was advised that the pump will need to be replaced.Customer was advised to revert to a back-up plan.

Manufacturer Narrative

The insulin pump was received with broken off end cap, minor scratched display window, cracked case at the display window corners, cracked reservoir tube lip and cracked battery tube threads.The drive sport disk was inspected and no anomaly was noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• 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: 5794995
• MDR Text Key: 50320133
• Report Number: 2032227-2016-14000
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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 Age: 81 YR
• Patient Weight: 87