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); Positioning Problem (3009)

Patient Problem Hypoglycemia (1912)

Event Date 05/06/2017

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

The customer reported via phone call that the insulin pump had a motor error alarm and multiple motor position encoder error alarms.Blood glucose level at the time of the incident was 65 mg/dl.Low blood glucose troubleshooting was declined.Customer stated that the device may have been exposed to high magnetic fields.The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.

Manufacturer Narrative

Motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform self test, off no power test, unexpected restart error test, occlusion test, prime/test, 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 during rewind.Pump had cracked reservoir tube lip.

• 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: 6614339
• MDR Text Key: 76947653
• Report Number: 3004209178-2017-52495
• 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
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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: 05/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• 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: 23 YR
• Patient Weight: 160