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

Model Number MMT-523NAP

Device Problems No Display/Image (1183); Failure to Prime (1492); Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

Patient Problem Hyperglycemia (1905)

Event Date 03/12/2014

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was unable to prime during prime/ compromised force sensor compromised force sensor 3 alarm tests due to faulty force sensor resistor (gold).The pump passed basic occlusion and displacement test.There was no motor error alarms noted.The motor tested ok.The pump had cracked reservoir tube lip, cracked battery tube threads, scratched display window, and cracked case near display window corners noted during visual inspection.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 pump had motor error alarm and prime/fill anomaly.The blood glucose at the time of the incident was 320 mg/dl.The customer states they disconnected while having an mri and when the reconnected the pump was unable to exit the "preparing to prime" loop.The customer states they did not receive a second series of beeps, nor did the numbers appear on the screen.The pump alarmed not reservoir, while there was a reservoir in the pump.The customer states the received a motor error, but was unable to confirm if there was a motor position encoder error alarm.Troubleshooting was not able to resolve the issue.The device will be 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: 6014313
• MDR Text Key: 57452956
• Report Number: 2032227-2016-27061
• 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: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAP
• Device Catalogue Number: MMT-523NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• 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: 58 YR
• Patient Weight: 76