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	Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
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.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
Information received by medtronic indicated that insulin pump had multiple pump error alarm.No harm requiring medical intervention was reported.The customer was assisted with troubleshooting.Customer did not hit any button combinations to get it to free up.Insulin pump had up arrow button did not work.Customer had already removed the battery due to multiple other issues.There was also an error that would pop up when you go to load the syringe that would push out the end.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received with missing segments due to cracked zebra connector.Unable to perform operating currents, self test, rewind test, displacement test and a21 alarm test or verify a21 alarm due missing segment.However, corrosion was found at the keypad traces.

• 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: 10301141
• Report Number: 2032227-2020-149997
• Device Sequence Number: 470749
• Product Code: OYC
• UDI-Device Identifier: 00613994743930
• UDI-Public: (01)00613994743930
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/17/2020

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: A3723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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: 120