MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported via phone call that the insulin pump received compromised force sensor system alert.The customer¿s blood glucose level at the time of incident was 148 mg/dl.The customer reported that insulin pump was unable to exit the preparing to prime loop.The customer pressed act on the rewind complete screen however, was unable to exit.The customer was helped to perform troubleshooting for clearing battery out limit alert.The customer performed troubleshooting for rewind fill tubing process and found that the insulin pump did not exit and the rewind complete bolus delivery loop and complete the fill tubing process successfully.The customer was advised that the device would be replaced and agreed to return the insulin pump for analysis.
Additional Manufacturer Narrative
The insulin pump passed the displacement test but not the compromised force sensor error alarm during the basic occlusion test due to loose and protruded drive support disk.The insulin pump was unable to perform the occlusion, a33 prime excessive no delivery test and unable to verify the prime fill anomaly due to compromised force sensor system error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 7366605
• Report Number: 3004209178-2018-59442
• Device Sequence Number: 18847395
• Product Code: OYC
• UDI-Device Identifier: 00613994312587
• UDI-Public: (01)00613994312587
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/24/2018

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A3722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 250