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

Model Number MMT-523NAL

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

Patient Problem Hyperglycemia (1905)

Event Date 04/26/2014

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed displacement test, rewind, basic occlusion and prime/ compromised force sensor tests.The pump was received stuck in motor error alarm loop during bolus/basal delivery.The motor was tested outside of the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Analysis was unable to confirm motor position encoder error alarm due to history file was overwritten.The pump had a cracked display window corner, scratched lcd window, cracked battery tube threads 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 pump had motor error alarm and motor position encoder error alarm.The blood glucose at the time of the incident was 132 mg/dl.The customer states the pump was exposed to a high magnetic field, during a cat scan, two prior to the call.The drive support cap appears intact.The customer stated there was a motor position encoder error alarm noted in the history.The customer states they were not able to rewind the pump.Troubleshooting was not able to resolve the issue.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The customer was advised that the insulin pump will need to be replaced.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: 6011128
• MDR Text Key: 57305990
• Report Number: 2032227-2016-26712
• 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: 04/26/2014

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2014
• Initial Date FDA Received: 10/07/2016
• 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: 32 YR