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

Model Number	MMT-523LNAS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump passed the displacement test.No pump error noted.The insulin pump had compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime test, excessive no delivery test and occlusion test or test for motor error alarm due to compromised force sensor system alarm.The insulin pump was received with minor scratched lcd window, cracked case at the display window corners, cracked case at the reservoir tube window corners, cracked reservoir tube window, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.
Event or Problem Description
The customer reported via phone call that the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was unknown at the time of the incident.The customer also reported that the insulin was squirting during manual prime process.Customer was rewinding pump and during the prime it was spraying insulin.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
• 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: 7362829
• Report Number: 3004209178-2018-59045
• Device Sequence Number: 61388
• Product Code: OYC
• UDI-Device Identifier: 00643169479630
• UDI-Public: (01)00643169479630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Device Lot Number: A3523LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 140