MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAP
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump had unresponsive esc and act buttons due to corroded keypad traces.No moisture damage on electronic assembly during visual inspection.
Event or Problem Description
The customer reported via phone call that the insulin pump got wet.The customer¿s blood glucose was unknown.The customer was not trust her insulin pump.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 9391467
• Report Number: 2032227-2019-125238
• Device Sequence Number: 484492
• Product Code: OYC
• UDI-Device Identifier: 00613994904294
• UDI-Public: (01)00613994904294
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2019

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A5523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR