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

Model Number	MMT-523NAP
Medical Device Problem Codes	Date/Time-Related Software Problem (2582); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.
Event or Problem Description
The customer reported via phone call that the insulin pump had rejected brand new batteries, clock was slow at times and the edge alone where the reservoir placed was cracked and had been a problem.Blood glucose level of the customer was unknown.The customer declined troubleshooting.The insulin pump will be returned for the analysis.
Additional Manufacturer Narrative
Device monitored for several days.Device received with all operating currents within specification and passed a21 error test and displacement test.No unexpected failed battery alarm anomalies noted.No frozen screen noted during test and time clock advances properly.Device received with broken reservoir tube lip.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 10048549
• Report Number: 2032227-2020-116886
• Device Sequence Number: 2917000
• Product Code: OYC
• UDI-Device Identifier: 00643169507197
• UDI-Public: (01)00643169507197
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/27/2020

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: B4523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 150