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

Model Number	MMT-523LNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received unable to perform all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/compromised force sensor system and excessive no delivery test due to completely broken reservoir tube lip.Pump received with minor scratched lcd window, broken reservoir tube lip, missing reservoir tube o ring, cracked case at the reservoir tube window corners, cracked belt clip slot, stained end cap sticker, stained address/serial number label and cracked battery tube threads.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.
Event or Problem Description
Customer's mom reported via phone call that insulin pump had cosmetic damage and damage reservoir compartment.The blood glucose at the time of the incident was unknown.The customer was assisted with troubleshooting.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 7612914
• Report Number: 3004209178-2018-82969
• Device Sequence Number: 1277457
• Product Code: OYC
• UDI-Device Identifier: 00643169479609
• UDI-Public: (01)00643169479609
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A3523LNAHJ
• 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: 09/25/2017
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 125