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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with detached/missing end cap.Unable to perform any test due to detached/missing end cap.
Event or Problem Description
The customer's parent reported via phone call that their daughter's insulin pump was broken.The customer fell and landed on the device.The bottom of the insulin pump came off as well as the wires and the battery.The customer¿s blood glucose level was unknown.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump was returned for analysis.

• 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: 8698497
• Report Number: 2032227-2019-16095
• Device Sequence Number: 1941505
• Product Code: OYC
• UDI-Device Identifier: 00643169446410
• UDI-Public: (01)00643169446410
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: B2523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 104