MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAS
Medical Device Problem Codes	Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
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
Customer reported via phone call that the sometimes buttons of insulin pump was stick also insulin pump received the pump error alarm.Customer's blood glucose level was unknown at the time of the incident.Customer also stated that insulin pump received random no delivery alarms and it was corrected by esc or act button.Customer also stated that they had to reset date and time during battery change also sometimes insulin pump rejects batteries.The device will not be returned for analysis.
Additional Manufacturer Narrative
No button error alarm noted during testing.Device had unresponsive esc and act buttons due to unlocked j2/lcd keypad connector.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify low battery, failed battery test, a21, no delivery alarms, e/a alarm or reset time or date anomaly due to unresponsive button.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
• 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: 9392229
• Report Number: 2032227-2019-125384
• Device Sequence Number: 448335
• Product Code: OYC
• UDI-Device Identifier: 00643169932982
• UDI-Public: (01)00643169932982
• 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,Followup
• Report Date (Section B): 02/26/2020

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-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Device Lot Number: A5523LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 11/30/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR