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

Patient Problem Hyperglycemia (1905)

Event Date 05/04/2014

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed the rewind basic occlusion test, prime test and displacement test.However, the insulin pump was received stuck in the motor error loop during bolus/basal delivery and motor position encoder error alarm confirmed in the history file.The drive support disk was inspected and no anomaly was noted during testing.Analysis was unable to verify motion sensor test failure alarm due to motor error alarms.No unexpected check setting alarms were noted during testing.The motor was tested outside the device and passed.The insulin pump was received with scratched lcd 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.(b)(4).

Event Description

The customer reported via phone call that they received a motor error alarm.The customer reported that they found motion sensor test failure alarm and a motor position encoder error alarm in the alarm history.The customer's blood glucose was 223 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 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 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: 6011148
• MDR Text Key: 57308826
• Report Number: 2032227-2016-26724
• 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: 05/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• 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: 05/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2014
• 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: 28 YR
• Patient Weight: 68