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

Model Number	MMT-723NAL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received with intermittent button response due to flattened dome switch on up arrow and down arrow button.The connector was inspected and locked on lcd board.No button error alarm during testing.Pump passed displacement test and self test.(b)(4).The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.
Event or Problem Description
The customer reported via phone call the insulin pump had a keypad anomaly.The customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump up and down buttons were less responsive.No significant events leading to keypad anomaly were observed.Keypad anomaly troubleshooting was performed and confirmed that time is advancing.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
The date provided with the initial report was incorrect.The correct date is (b)(6) 2019.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 8341904
• Report Number: 3004209178-2019-55881
• Device Sequence Number: 13941739
• Product Code: OYC
• UDI-Device Identifier: 00643169693791
• UDI-Public: (01)00643169693791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: B6723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 195