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

Model Number	MMT-723LNAS
Medical Device Problem Codes	Failure to Cycle (1142); Mechanical Problem (1384); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
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.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had compromised force sensor system alarm.It was reported that the piston not rewinding and was unable to complete the priming.Customer stated that the drive support cap appeared normal.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit was unable to prime and then alarmed a33 (compromised force sensor system) during the prime/a33 test at 4.0 lbs due to moisture damage on the fsr (gold).Unable to perform the occlusion test, excessive no delivery test and the displacement accuracy test due to prime anomaly and a33 (compromised force sensor system) alarm.All operating currents are within specification.Off no power alarm functions properly.Unit passed the displacement test, rewind, basic occlusion test, self test and a21 error test.Unable to complete the functional testing or verify drive/motor anomaly due to prime anomaly and a33 (compromised force sensor system) alarm.During visual inspection, the electronic assembly and motor had moisture damage.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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: 9942252
• Report Number: 3004209178-2020-96835
• Device Sequence Number: 14168486
• Product Code: OYC
• UDI-Device Identifier: 00643169478602
• UDI-Public: (01)00643169478602
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/06/2020

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-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A4723LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 150