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

Model Number MMT-723NAS

Device Problems Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

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

Event Date 10/18/2016

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.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.

Event Description

The customer reported via telephone call that the insulin pump alarmed for a motor error.The drive support cap was sticking out.The customer did not recall the blood glucose reading.She had not pressed on the cap while connected to the insulin pump.She was advised to discontinue use of the insulin pump and to revert to a backup plan per a health care professional's instructions.She was advised that the insulin pump would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

The insulin pump was received unable to prime during prime test and alarmed motor error during basic occlusion test due to loose protruded drive support disk.The motor passed motor test.The insulin pump had minor scratched lcd window, cracked case near the display window corners, broken reservoir tube lip and missing the end cap sticker.

• 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6047381
• MDR Text Key: 58465733
• Report Number: 2032227-2016-33724
• 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: 02/23/2017

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-723NAS
• Device Catalogue Number: MMT-723NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• 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: 61 YR