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

Model Number	MMT-723LNAB
Medical Device Problem Codes	Failure to Cycle (1142); Mechanical Problem (1384); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
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 insulin pump had compromised force sensor system alarm.No harm requiring medical intervention was reported.The customer was assisted with troubleshooting.The customer stated the battery was not previously used.Customer stated the they received no delivery alarm when rewinding the insulin pump.Customer stated the insulin squirt out during manual prime.Customer stated they are unable to exit the preparing to prime loop.Customer stated they did not receive 2nd series of beeps nor did numbers appear on the screen.The device will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test and occlusion test.No unexpected no delivery alarm or a33 alarm noted.No rewind anomaly noted.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• 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: 9833832
• Report Number: 3004209178-2020-85449
• Device Sequence Number: 1828132
• Product Code: OYC
• UDI-Device Identifier: 00643169933132
• UDI-Public: (01)00643169933132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/01/2020

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-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A6723LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 233