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

Model Number	MMT-722NAL
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
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.
Event or Problem Description
Information received by medtronic indicated that insulin pump had motor error alarm.No harm requiring medical intervention was reported.Customer reported several battery alerts.Troubleshooting was performed.The alarm history was reviewed and there were failed battery test alerts.Customer sated that drive support cap was loose and stated that insulin pump was not exposed to high magnetic field.The device will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test.Device received a33 alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform the a21 error test, prime/a33 test, excessive no delivery test and occlusion test or test for motor error alarm due to a33 alarm.Device received with normal operating current.Device passed self test.Device passed off no power test.Device received with cracked battery tube threads and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• 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: 9881079
• Report Number: 3004209178-2020-90347
• Device Sequence Number: 11559156
• Product Code: OYC
• UDI-Device Identifier: 00613994622570
• UDI-Public: (01)00613994622570
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: A8722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1