MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2017
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 compromised force sensor system alarm on the insulin pump.Customer¿s blood glucose level was unknown.Troubleshooting for the prime rewind was performed.Customer advised they were unable to rewind and when they attempted to prime the insulin pump all of the insulin was pushed out.Customer advised the drive support cap was flush.Customer advised during the seating of the force the sensor did not detect the reservoir.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Findings: pump passed the displacement test.Unit received compromised forced sensor alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected alarm error test, prime test, excessive no delivery test and occlusion test due to compromised forced sensor alarm.Pump received with normal operating current.Pump passed self test.Pump passed off no power test.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked at the reservoir tube window corners, cracked belt clip slot, missing end cap sticker and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6787048
• Report Number: 2032227-2017-36049
• Device Sequence Number: 1852683
• Product Code: OYC
• UDI-Device Identifier: 00613994312624
• UDI-Public: (01)00613994312624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/13/2017

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A3522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 07/16/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 150