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	Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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 the insulin pump had damage.Customer's blood glucose level was unknown at the time of the incident.The customer was assisted with troubleshooting.Customer stated that the insulin pump had battery life diminished, o ring from reservoir area missing and insulin pump had random no delivery alarms.The device will not be returned for analysis.
Additional Manufacturer Narrative
A test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.Unable to perform rewind test, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and displacement test or verify no delivery alarm due to completely broken reservoir tube lip.Device had cracked battery tube threads, missing reservoir tube o-ring.

• 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: 8194832
• Report Number: 2032227-2018-78776
• Device Sequence Number: 2016142
• Product Code: OYC
• UDI-Device Identifier: 00643169202337
• UDI-Public: (01)00643169202337
• 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): 03/06/2020

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: B1523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/25/2018
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 122