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

Model Number	MMT-523LNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2017
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer was reported via phone call that, the customer received with unexpected restart alarm after battery change.The blood glucose was 80 mg/dl at the time of the incident.Troubleshooting steps were guided for unexpected restart alarm.Customer also reported low battery alarm.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Pump passed the unexpected restart error test and displacement test.No unexpected restart error alarm was noted.Pump had cracked case at display window corner, battery tube threads, reservoir tube window, reservoir tube lip, cracked case at reservoir tube window corner, stained end cap sticker, minor scratched and cracked display window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• 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: 6971349
• Report Number: 2032227-2017-59840
• Device Sequence Number: 1934408
• Product Code: OYC
• UDI-Device Identifier: 00643169479616
• UDI-Public: (01)00643169479616
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 03/02/2018

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A3523LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 145