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

Model Number	MMT-722NAS
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform the displacement test, rewind, basic occlusion test, occlusion test, prime, compromised forced sensor system test and excessive no delivery test or verify prime, fill, low battery alarm, no excessive no delivery, occlusion alarm, failed battery alarm and low battery alarm due to motor error alarms.Pump received with loose drive support disk, broken battery tube threads and cracked reservoir tube lip.Cracked case at the reservoir tube window corners and broken reservoir tube window.The test infusion set and reservoir does lock into place.(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 there was crack around the battery compartment and near reservoir window.Customer stated that insulin pump had random no delivery alarm and rewind was slower than in the past.Customer also stated that insulin shoots out of infusion set.Customer stated that there was scratches on the display.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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; * 00777-3869
• MDR Report Key: 10500302
• Report Number: 2032227-2020-173184
• Device Sequence Number: 6132377
• Product Code: OYC
• UDI-Device Identifier: 00613994402011
• UDI-Public: (01)00613994402011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/07/2020

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A5722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 160