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

Model Number	MMT-722NAS
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that their insulin pump had buttons harder to pressing and screen went black a couple of times.The customer¿s blood glucose was unknown at the time of incident.Customer reported that they received frequent unexplained no delivery alarms, rainbow effect occasionally on screen, buttons are worn, could not see esc up and down lettering, crack on reservoir screen and scratches on body and screen.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
All buttons functioning properly.No damage/unlocked j2/lcd keypad connector during visual inspection noted.Device power up properly after battery installation.No blank display or missing segment or partial display noted.Unit was received with normal operating currents and passed self-test, a21 error test.No unexpected off no power, low battery, battery out limit and failed battery test alarms during testing.Also, device passed rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No unexpected no delivery alarm noted during testing.Unit had cracked lcd window, broken reservoir tube lip, cracked case at display window corners, cracked reservoir tube window, cracked case at reservoir tube window corners.

• 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 MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8630612
• Report Number: 2032227-2019-05133
• Device Sequence Number: 13863943
• Product Code: OYC
• UDI-Device Identifier: 00613994223746
• UDI-Public: (01)00613994223746
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: A000093830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 180