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 Problem Intermittent Continuity (1121)

Patient Problem Hypoglycemia (1912)

Event Date 09/27/2013

Event Type  Injury  

Manufacturer Narrative

Device had no button response due to corroded keypad traces.No creased dome switches noted on keypad.Unable to test for battery out limit alarm or insulin pump communication with a test blood glucose meter due to no button response.Used a test keypad, device responded properly to button presses.No frozen screen noted and the time advanced.Device had a severely scratched display window.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

Customer reported via phone call that the buttons were not responsive intermittently.Customer's blood glucose was 39 mg/dl.Customer just woke up and hasn't eaten.Customer checked blood glucose again and it was 61 mg/dl.During troubleshooting, found battery out limit alarm in history.Down button had delayed response.Customer was advised to discontinue use of the device and revert to a back-up plan per health care professionals' instructions.Customer was advised that the insulin pump will be replaced.Customer agreed to return the device 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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5445682
• MDR Text Key: 38514630
• Report Number: 3004209178-2016-87655
• 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: 10/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/03/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2013
• 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 Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 95