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

Model Number MMT-723NAH

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.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

Customer reported via phone call that the insulin pump alarmed motor position encoder error.Customer's blood glucose level was not reported.Customer stated that the insulin pump was exposed to magnetic resonance imaging.The drive support cap was normal.Customer also reported motor error alarm.Customer was advised to discontinue from the insulin pump and revert to a backup plan per health care instruction.Insulin pump will be not returning for analysis.

Manufacturer Narrative

Findings: motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform self test, off no power test, unexpected restart alarm error test, occlusion test, primetest, excessive no delivery test, displacement test due to motor error alarm.Pump passed idle current test and run current test.Unable to verify motor position encoder error alarm due to motor error alarm.Pump received with minor scratched display window and cracked case at display window corners.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 6697529
• MDR Text Key: 79615500
• Report Number: 2032227-2017-26956
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507227
• UDI-Public: (01)00643169507227
• 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: 09/06/2017

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: B5723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 09/06/2017
• 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: 40 YR
• Patient Weight: 161