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

Model Number	MMT-523LNAB
Medical Device Problem Codes	Failure to Cycle (1142); Device Difficult to Program or Calibrate (1496); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2019
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
The customer reported via phone call that the insulin pump alarmed compromised force sensor system.The customer's blood glucose value was 377 mg/dl.The customer reported that the keypad was responding.Customer reported they were not able to clear the alarm.Customer stated they were not able to rewind the pump.Customer was advised the insulin pump will need to be replaced.Advised to discontinue use of the insulin pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to corroded keypad traces.Device received with reservoir tube lip completely broken off noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Unable to perform test to confirm compromised force sensor system alarm due to reservoir tube lip completely broken off.No frozen screen anomaly noted.Device passed self test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB
• 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: 8360881
• Report Number: 3004209178-2019-58637
• Device Sequence Number: 16625281
• Product Code: OYC
• UDI-Device Identifier: 00643169151277
• UDI-Public: (01)00643169151277
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/10/2019

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-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Device Lot Number: A2523LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 179