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

Model Number MMT-722LNAB

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

Patient Problem Hyperglycemia (1905)

Event Date 04/19/2014

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed the rewind, basic occlusion, prime and displacement tests.The insulin pump was received with stuck motor error alarm loop during bolus delivery and motor position encoder error alarm confirmed in the history file.The motor was tested outside to the device and passed.The motor may have had an intermittent failure that was not detected during our testing.The displacement test was functioning properly.No motion sensor test failure alarm during testing.The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, scratched lcd window, scratched reservoir tube window and scratched 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.

Event Description

The customer reported via phone call that they received a motor error alarm, several motion sensor test failure alarms and a motor position encoder error alarm.The customer's blood glucose was 150 mg/dl at the time of incident.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was exposed to mri and x-rays.The customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump will be 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: 5987799
• MDR Text Key: 56352740
• Report Number: 2032227-2016-22432
• 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: 04/19/2014

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-722LNAB
• Device Catalogue Number: MMT-722LNAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2014
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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: 42 YR
• Patient Weight: 98