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

Model Number	MMT-523NAS
Medical Device Problem Codes	No Display/Image (1183); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
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.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 that the insulin pump had blank display.Customer's blood glucose level was 171 mg/dl, 69 mg/dl and today it was 67 mg/dl.Customer reported that they received failed battery test alarm and battery out limit alarm as well.Customer was assisted with troubleshooting for failed battery test.Customer woke up this morning insulin pump was beeping 6 times and it was dead.Customer stated they did not received a request to rewind insulin pump.Customer stated that the issue started within the last week it went dead one day last week, so they replaced the battery.Customer reported this week he had put several different batteries in and it was still gave him messages that the battery was not sufficient and they were new batteries.Customer was explained that the battery out limit alarm during normal use may indicate a loose battery cap.Customer was advised that will send a replacement battery cap and advised to monitor insulin pump.Customer was advised that if the battery cap replaced did not resolve the issue he will need to go through upgrade insulin pump.Insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 9535082
• Report Number: 2032227-2019-140364
• Device Sequence Number: 11628383
• Product Code: OYC
• UDI-Device Identifier: 00643169077683
• UDI-Public: (01)00643169077683
• 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
• Report Date (Section B): 12/31/2019

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: A6523NASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 86