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	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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 the piston of the insulin pump was frozen.Customer stated that the insulin pump had no delivery alarms.Customer was assisted with troubleshooting for no delivery alarms.Customer not tried different cannula lengths.Customer stated the tubing was not bent or kinked.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
A test p-cap and reservoir locks into place inside the reservoir compartment properly.Device was received with the operating currents within specification.And passed the self test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test, and the delivery accuracy test.Device alarmed a21 after battery change due to connector on interface board voltage leak.No excessive no delivery alarms, motor error alarms, or drive/motor anomaly noted during testing.The motor passed the motor test.

• 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: 9768425
• Report Number: 3004209178-2020-77908
• Device Sequence Number: 2216964
• Product Code: OYC
• UDI-Device Identifier: 00643169478602
• UDI-Public: (01)00643169478602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/21/2020

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: 03/11/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 111