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

Model Number MMT-722NAP

Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

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

Event Date 03/01/2014

Event Type  malfunction  

Manufacturer Narrative

Failure analysis noted that the pump alarmed motor error during rewind due to motor encoder signal out of phase.They were unable to test for motion sensor test failure alarm and motor position encoder error in history due to motor error alarms during rewind.The pump had broken belt clip slot, cracked battery tube threads and scratched lcd window and case.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.(b)(4).

Event Description

The customer reported via phone call that the insulin pump had motor error alarm, motor position encoder error alarm, and motion sensor test failure alarm.The blood glucose at the time of the incident was unknown.The drive support disk was normal.The customer had an mri.They were unable to rewind the pump.Troubleshooting was not able to resolve the issue.The device was returned for analysis.

• Brand Name: PARADIGM REAL-TIME 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: 6003471
• MDR Text Key: 57252993
• Report Number: 2032227-2016-26536
• 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: 03/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722NAP
• Device Catalogue Number: MMT-722NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2014
• 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: 62 YR
• Patient Weight: 88