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

Model Number	MMT-723NAP
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that the insulin pump did not bolus 3 to 4 times in the last week.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with all operating currents within spec and passed functional testing including the rewind, a21 error test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No possible under delivery anomaly noted.Device was downloaded to care link pro properly and all bolus delivered were found at the care link report.Device passed the delivery accuracy test at 0.08750 inches.Device received with cracked reservoir tube lip, cracked battery tube threads, broken belt clip slot and cracked case from display window corner.The test infusion set and reservoir does lock into place.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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: 10091199
• Report Number: 2032227-2020-122753
• Device Sequence Number: 19684991
• Product Code: OYC
• UDI-Device Identifier: 00643169446465
• UDI-Public: (01)00643169446465
• 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): 12/21/2020

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: B3723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 88