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

Model Number	MMT-723NAS
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
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 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
Customer reported via phone call that the insulin pump had no delivery and button error.Customer's blood glucose level was unknown.Customer also stated that the insulin pump had button error even though the buttons were working.Trouble shooting was performed for no delivery alarm and event was resolved by changing complete set.It was also reported that the time on insulin pump was advances.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received with all buttons responding properly.No damage on keypad assembly.No unlocked lcd keypad connector.Device received with complete broken reservoir tube lip.Unable to perform basic occlusion test and occlusion test or verify no excessive no delivery or occlusion alarm due to broken reservoir tube lip.However, device passed rewind test, displacement test, prime/a33 test and excessive no delivery test.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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: 9400016
• Report Number: 2032227-2019-126334
• Device Sequence Number: 19445529
• Product Code: OYC
• UDI-Device Identifier: 00613994904355
• UDI-Public: (01)00613994904355
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/26/2020

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-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: A5723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR