MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAB

Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer was reported via phone call that pump alarmed the motor position encoder error.The blood glucose value was unknown at the time of incident.Troubleshooting assisted for motor error and motor position encoder error and advised to discontinue the pump.The drive support cap appears normal.The pump has been exposed to high magnetic field.Customer advised to discontinue use of the pump to revert to the back-up plan.The insulin pump will be returned for analysis.Customer competed the troubleshooting guide.

Manufacturer Narrative

Pump received with normal operating currents and passed the self-test.Pump failed the displacement test (54.1 units remaining on the status screen) followed by a motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform the basic occlusion test, occlusion test, excessive no delivery test, prime test, and error test due to motor error alarms.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked belt clip slot, cracked lcd window and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 6891943
• MDR Text Key: 87467844
• Report Number: 2032227-2017-52414
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446434
• UDI-Public: (01)00643169446434
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: B3723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• 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: 58 YR