MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-722LNAL

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

Patient Problem Hyperglycemia (1905)

Event Date 04/14/2014

Event Type  malfunction  

Manufacturer Narrative

Failure analysis noted that the pump passed basic occlusion, prime/compromised force sensor system 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 displacement test functioned properly.There was no motion sensor test failure alarm.The pump had cracked reservoir tube lip, scratched display window and cracked case near the display window corners.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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.

Event Description

The customer reported via phone call that the pump had motor error alarm and motor position encoder error alarm.The blood glucose at the time of the incident was 217 mg/dl.The customer had to go through a metal detector eight months ago.They were unable to rewind the pump.There was a motion sensor test failure alarm in the pump history.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 MINIMED; 18000 devonshire street; northridge CA 91325
• 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: 5987680
• MDR Text Key: 56360110
• Report Number: 2032227-2016-22425
• 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: 04/14/2014

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-722LNAL
• Device Catalogue Number: MMT-722LNAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: 23 YR
• Patient Weight: 81