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

Model Number MMT-523NAL

Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 01/09/2017

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 the reservoir would not stay in the reservoir compartment.Customer's blood glucose was unknown.Customer's blood glucose was 337 mg/dl.Reservoir compartment threading gasket was broken off.Customer was advised to discontinue use of the device and revert to a back-up plan per health care professionals' instructions.Customer was advised that the insulin pump will be replaced.Customer agreed to return the device for analysis.

Manufacturer Narrative

The insulin pump received with minor scratched display window, broken off battery tube threads, cracked reservoir tube, cracked reservoir tube window, missing reservoir tube o-ring and completely broken off reservoir tube lip.The reservoir tube lip completely broken off and test reservoir will not lock/click in place.The insulin pump passed idle current test, run current test, self-test, off no power test, unexpected restart error test, prime test, excessive no delivery test, displacement test and rewind test.Unable to perform basic occlusion test and occlusion test due to completely broken off reservoir tube lip.

• 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: 6293555
• MDR Text Key: 66560897
• Report Number: 3004209178-2017-88270
• 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,Followup
• Report Date: 02/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAL
• Device Catalogue Number: MMT-523NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2017
• 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: 49 YR