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

Model Number	MMT-523NAB
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
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.The device has been returned, but not yet evaluated.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 also stated that they had button error alarm.The customer¿s blood glucose level was 215 mg/dl.The customer stated that pump got displayable history crc check failed on startup.Troubleshooting was done for keypad anomaly.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Insulin pump had pump history crc failed.Alarm in alarm history file.Pump history crc failed.Alarms due to corrupted history files.Insulin pump passed displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test and occlusion test.No motor error alarm noted.The motor was tested outside of the device and passed.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 7821668
• Report Number: 2032227-2018-19475
• Device Sequence Number: 1510869
• Product Code: OYC
• UDI-Device Identifier: 00643169202306
• UDI-Public: (01)00643169202306
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 12/10/2018

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A8523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 144