MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723KNB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723KNB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2019
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.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
Customer's mother reported via phone call that the insulin pump received button error.The customer¿s blood glucose level was unknown at the time of the incident.Customer got wet from rain when they received the alarm.Customer stated that the buttons were unresponsive.Customer assisted with the troubleshooting and stated that the time was advances on insulin pump.Customer was unable to clear the alarm and buttons were unresponsive after changing new battery.The customer was advised to discontinue use of the insulin pump and revert to the backup plan.Customer was advised that the insulin pump needed to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with no (act, up and escape) button response due to corroded keypad traces.No button error alarm and no frozen display anomaly during testing noted.Unable to perform all functional testing including the displacement, operating currents, a21 error test, rewind, basic occlusion, occlusion, prime a33 and excessive no delivery test due to buttons not responding.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723KNB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8943385
• Report Number: 2032227-2019-54490
• Device Sequence Number: 18914255
• Product Code: OYC
• UDI-Device Identifier: 00613994743794
• UDI-Public: (01)00613994743794
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/20/2019

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-723KNB
• Device Catalogue Number: MMT-723KNB
• Device Lot Number: A000170213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/18/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 200