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

Model Number	MMT-523NAL
Medical Device Problem Codes	Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
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
Customer reported via phone call that insulin pump shut off without warning low life.The customer¿s blood glucose level was unknown at the time of the incident.Customer also reported that battery life did not last full seven days, insulin pump rejected new battery, failed battery test and unexplained no delivery alarm.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.No excessive no delivery/occlusion alarm noted.No unexpected battery out limit alarm anomalies noted.No unexpected failed battery alarm anomalies noted.No unexpected low battery alarm anomalies noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 8904853
• Report Number: 2032227-2019-48328
• Device Sequence Number: 11400159
• Product Code: OYC
• UDI-Device Identifier: 00643169693746
• UDI-Public: (01)00643169693746
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/13/2020

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: B5523NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 64