MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723RNAB

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that the insulin pump alarmed motion encoder error.Customer blood glucose at the time of incident was 105 mg/dl.The incident occurred while eating dinner.Customer alarmed motor error occurred.Customer stated that the insulin pump was exposed to high magnetic field while getting magnetic resonance imaging.Drive support was flushing.Customer also reported motor alarm.Customer was advised to discontinue from the insulin pump and revert to a backup plan per healthcare instruction.Insulin pump will be returning for analysis.

Manufacturer Narrative

Pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No motor error alarm noted.Motor passed motor test.Unable to verify motor position encoder error alarm in the alarm history due to history file overwritten with corrupted history files.Corrupted history file alarms due to a corrupted history file.Pump received with minor scratched lcd window, cracked case, cracked case at the display window corners, cracked case at the reservoir tube window corners, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6874861
• MDR Text Key: 87216994
• Report Number: 2032227-2017-49787
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221567
• UDI-Public: (01)00643169221567
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A000290053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Weight: 215