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

Model Number	MMT-723NAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record was converted.For additional information about the analysis, please see sap.No button response due to corroded keypad traces.No button error alarms noted.Moisture damage found on electronics assembly and corroded motorhome switch.Ea (b)(6) 2013.
Event or Problem Description
The customer reported via phone call the insulin pump alarmed button error.The customer¿s blood glucose level was 158 mg/dl at the time of the incident.The customer stated that the insulin pump was exposed to moisture.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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: 7636704
• Report Number: 3004209178-2018-84963
• Device Sequence Number: 2412990
• Product Code: OYC
• UDI-Device Identifier: 00613994904348
• UDI-Public: (01)00613994904348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/25/2018

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: A4723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2013
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 57