MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723LNAS

Device Problems Break (1069); Component Falling (1105); Malposition of Device (2616); Material Deformation (2976)

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

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Unit had minor scratched lcd window, cracked lcd window, cracked case at display window corner, cracked battery tube threads, a test reservoir was installed and did not lock in place due to complete broken reservoir tube lip and missing o-ring (reservoir tube).No belt clip assembly received with pump.Was unable to verify belt clip anomaly.

Event Description

Customer reported via phone call to have physical damage of insulin pump.Customer reported that reservoir compartment was broken and reservoir could not stay in place.Customer does not know how damage occurred, but may have been dropped.Customer's blood glucose was 115 mg/dl.Customer was advised that insulin pump would need to be replaced.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5710357
• MDR Text Key: 47227433
• Report Number: 3004209178-2016-52774
• 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: Patient
• Type of Report: Initial
• Report Date: 05/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR