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

Model Number	MMT-723LNAH
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Connection Problem (2900); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
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 retainer ring was loosened and reservoir does not lock into place when inserted into insulin pump.The customer reported failed battery test and sometimes pump would reject brand new batteries with crack in the casing near the top of the battery compartment.Customer stated sometimes the up buttons had to be pressed twice before the button will activate and 2 tiny scratches on the display, did not affect readability.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with cracked battery tube threads noted.The reservoir tube look normal.The test reservoir p-cap was able to lock in place.Device received with intermittent button response due to flattened dome switch on esc, and up arrow button.The connector was inspected and locked on lcd board.Device passed displacement test, self test, off no power test, a21 error test and all operating currents tested within the specification.No failed battery test alarm were noted.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 10243501
• Report Number: 2032227-2020-142959
• Device Sequence Number: 535987
• Product Code: OYC
• UDI-Device Identifier: 00643169513884
• UDI-Public: (01)00643169513884
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/09/2020

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-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A5723LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 76