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

Model Number	MMT-523NAH
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call the insulin pump alarmed button error.The customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump buttons are hard to push and screen is hard to read.The insulin pump is not being replaced or is expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump received with intermittent button response at act due to moisture damage to the keypad traces.No button error alarm during testing.Insulin pump passed displacement test and self test.Stained lcd display window noted.No rewinding anomaly noted.
Additional Manufacturer Narrative
Device received with intermittent button response at act due to moisture damage to the keypad traces.No button error alarm during testing.Device passed displacement test and self test.Stained lcd display window noted.No rewinding anomaly noted.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 7670254
• Report Number: 3004209178-2018-89255
• Device Sequence Number: 2771755
• Product Code: OYC
• UDI-Device Identifier: 00643169202313
• UDI-Public: (01)00643169202313
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2019

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: B1523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/09/2018
• Supplement Date Received by Manufacturer: 03/08/2019; 08/16/2019
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 03/14/2019; 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 34