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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
The customer reported via phone call the insulin pump received an unexpected restart error and button error alarm.The customer¿s blood glucose level was unknown at the time of incident.The customer states was taking a shower and when they came out the pump received an unexpected restart error alarm.The customer also reported pump error due to replacing the battery.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Pump passed the displacement test and unexpected restart error alarm test.No unexpected restart error alarm anomalies noted.The device passed self test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• Common Device Name: 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
• MDR Report Key: 7440888
• Report Number: 3004209178-2018-65933
• Device Sequence Number: 1963138
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A7723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 175