MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAP
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2020
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
The customer reported that the insulin pump alarmed compromised force sensor system.It was also mentioned that the drive support cap was sticking out.Blood glucose level was unknown at the time of the incident.No further details were provided.Customer was advised to discontinue use of the insulin pump and revert to a back-up plan per healthcare provider's instruction.The customer will receive a replacement insulin pump and will return the one they currently use for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However device alarmed motor error during basic occlusion test due to loose or protruded drive support disk.Unable to perform occlusion test, prime/a33 test, excessive no delivery test or verify a33 alarm due to motor error.The test reservoir p-cap was able to lock in place.(b)(4).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP
• 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: 9973710
• Report Number: 2032227-2020-105597
• Device Sequence Number: 16831903
• Product Code: OYC
• UDI-Device Identifier: 00613994622563
• UDI-Public: (01)00613994622563
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/24/2020

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-722NAP
• Device Catalogue Number: MMT-722NAP
• Device Lot Number: A6722NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 155