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

Model Number MMT-523NAS

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

Patient Problem Hyperglycemia (1905)

Event Date 02/06/2014

Event Type  malfunction  

Manufacturer Narrative

Failure analysis noted that the pump passed rewind, basic occlusion and displacement tests.The pump was stuck in a motor error alarm loop during bolus delivery and motor position encoder error alarm noted in the history file.The motor was tested outside of the device and passed.The motor may have had intermittent failure that was not detected during the testing.The pump had scratched lcd window and cracked reservoir tube lip.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 and motor position encoder error alarm.The blood glucose at the time of the incident was 169 mg/dl.The customer was changing the infusion set when the motor error alarm was received.The drive support disk was normal.The customer had an x-ray with the pump on.They were able to rewind the pump.Troubleshooting was performed.The device was returned for analysis.

• 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: 6003617
• MDR Text Key: 57186921
• Report Number: 2032227-2016-26441
• 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: 02/06/2014

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 10/06/2016
• 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: 53 YR
• Patient Weight: 79