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

Model Number MMT-723NAS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2017

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).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

The customer reported via phone call that the insulin pump had a motor error alarm, a motor position encoder error alarm, and an additional error alarm.The customer stated that the device had been exposed to high magnetic fields.Blood glucose level at the time of the incident was 126 mg/dl.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

The information provided for the product code and common device name with the initial report was incorrect.The correct information has been provided with this report.

Manufacturer Narrative

Findings: motor error alarm during rewind due to motor encoder signal out of phase.Pump passed the stop current and run current tests.Unable to verify motor position encoder error alarm, motion sensor test failure alarm or perform the self test, off no power test, unexpected restart error test, displacement test, prime test, occlusion test and no delivery test due to motor error alarm.Pump had cracked case at display window corner, battery tube threads, reservoir tube lip, belt clip slot and minor scratched display window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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: 6675205
• MDR Text Key: 78774025
• Report Number: 2032227-2017-24478
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507258
• UDI-Public: (01)00643169507258
• 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,Followup
• Report Date: 08/30/2017

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-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B5723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 08/09/2017
• Supplement Dates FDA Received: 08/18/2017; 08/30/2017
• 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: 42 YR