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

Model Number MMT-723RNAP

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Reset Problem (3019)

Patient Problem Hyperglycemia (1905)

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with a stuck motor error alarm loop during bolus delivery.The motor was tested outside the device and passed.Motor may have had an intermittent failure that was not detected during testing.Unable to perform occlusion test and excessive no delivery test due to motor error alarms.Pump passed displacement test, rewind test, basic occlusion test and prime/a33 test.Unable to confirm e70 alarm due to overwritten history file.Drive support cap was inspected and no anomaly was noted.

Event Description

The customer reported via phone call that they received a motor error alarm.The customer's blood glucose was over 300 due to not being on the pump.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was not exposed to high magnetic fields.The customer stated that they were able to rewind the insulin pump.The customer reported that the alarm history contains both motor position encoder error alarm and motor error alarm.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 MMT-723RNAP
• 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 ; 8185464805
• MDR Report Key: 7712393
• MDR Text Key: 115100091
• Report Number: 2032227-2018-08612
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221499
• UDI-Public: (01)00643169221499
• 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: Other
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000290378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Date Manufacturer Received: 03/28/2018
• 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: 60 YR
• Patient Weight: 195