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

Model Number	MMT-722NAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2017
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
It was reported that the insulin pump alarmed compromised force sensor system.It was also mentioned that the drive support cap was loose.Blood glucose level was unknown at the time of the incident.No further details were provided.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The pump alarmed compromised force sensor system during the basic occlusion test due to loose/protruded drive support disk.Pump passed the displacement test.Unable to perform the prime test, occlusion test and no delivery test due to compromised force sensor system alarm.Pump had cracked case at display window corners, cracked reservoir tube lip, minor scratched and cracked display window, missing end cap sticker and stained address/serial number label.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH
• 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: 6616423
• Report Number: 3004209178-2017-52866
• Device Sequence Number: 809096
• Product Code: OYC
• UDI-Device Identifier: 00613994622587
• UDI-Public: (01)00613994622587
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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-722NAH
• Device Catalogue Number: MMT-722NAH
• Device Lot Number: A2722NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1