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

Model Number	MMT-523RNAS
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Priming Problem (4040)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that the insulin pump had keypad anomaly.The customer¿s current blood glucose level was 331 mg/dl.Customer has been experiencing highs blood glucose and notices high after lunch.Customer was this morning on a fast and blood glucose was 268 mg/dl, when she went to rewind the insulin pump she had to press the button 2 to 3 times to get it to rewind.Customer stated when she would press the button it went back to the home screen, it went back to rewind and the act button was not responding to rewind.Customer treated high blood glucose with bolus.Customer declined troubleshooting for prime anomaly.The device will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, basic occlusion test, prime or a33 test, excessive no delivery test , occlusion test, no anomaly noted.All buttons functioning properly.No button error alarm during testing.No moisture or corroded keypad found.No flatted keypad.Connector was inspected and locked on lcd board.Device passed self test.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, basic occlusion test, prime or a33 test, excessive no delivery test , occlusion test, no anomaly noted.All buttons functioning properly.No button error alarm during testing.No moisture or corroded keypad found.No flatted keypad.Connector was inspected and locked on lcd board.Device passed self test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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: 9237109
• Report Number: 2032227-2019-109404
• Device Sequence Number: 1645954
• Product Code: OYC
• UDI-Device Identifier: 00643169476509
• UDI-Public: (01)00643169476509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2020

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-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A0523RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 01/22/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 01/16/2020; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 127