MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with blank display due to moisture damaged electronic assembly.Also moisture damage motor and vibrator during visual inspection.Unable to perform operating current test, unexpected restart error test, displacement test due to blank display.Unit had cracked reservoir tube lip, cracked case at reservoir tube window corners.
Event or Problem Description
Customer reported via phone call that the insulin pump did not work.The customer¿s blood glucose level was 203 mg/dl at the time of the incident.Customer stated because they forgot to take off the insulin pump and got into the pool for 30 minutes and now did not work.Customer stated that the whole liquid crystal display screen was blacked out and there was water under screen it did start up every now and then but stops and none of the buttons function at all there was water inside the insulin pump at the motor, prior to getting the insulin pump.Troubleshooting was performed.Customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan per health care professional instructions.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 8882066
• Report Number: 2032227-2019-44769
• Device Sequence Number: 2447716
• Product Code: OYC
• UDI-Device Identifier: 00643169478589
• UDI-Public: (01)00643169478589
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/11/2019

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A4723LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 295