MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/03/2017
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.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that the customer received compromised force sensor system alarm during rewind/prime sequence.Customer's blood glucose was 300mg/dl.Customer was assisted with troubleshooting and was advised to refer back-up plan, per health care professional's instructions.Customer decline troubleshooting for high blood glucose.Insulin pump will be returned for analysis and a replacement pump will be sent.
Additional Manufacturer Narrative
Motor error alarm during the basic occlusion test due to loose drive support disk.No unexpected compromised forced sensor alarm.Motor passed motor test.Unit had minor scratched lcd window, cracked case near display window corners, cracked battery tube threads, broken belt clip slot, cracked reservoir tube lip, reservoir tube cracked, cracked reservoir tube window, and cracked lcd window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 6905002
• Report Number: 2032227-2017-54417
• Device Sequence Number: 10961248
• Product Code: OYC
• UDI-Device Identifier: 00613994904331
• UDI-Public: (01)00613994904331
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/08/2018

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-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: A5723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Initial Date Received by Manufacturer: 09/10/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 178