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

Model Number	MMT-523NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/05/2018
Type of Reportable Event	Serious Injury
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 the insulin pump had a keypad anomaly and had an unexpected restart alarm.The customer¿s blood glucose was 274 mg/dl at the time of incident.Customer stated that the insulin pump alarmed unexpected restart alarm and would not turn on.Customer also reported that the insulin pump buttons were unresponsive.No significant events leading to keypad anomaly were observed 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 device powered up properly after battery installation.No blank display or audio/beep anomaly noted.However, unit received with button error alarm and had unresponsive esc, act and down buttons due to corroded keypad traces.Unable to perform operating currents, self-test, unexpected restart error test and displacement test or verify unexpected restart error alarm due to unresponsive button.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 7567845
• Report Number: 3004209178-2018-77052
• Device Sequence Number: 11278402
• Product Code: OYC
• UDI-Device Identifier: 00643169077676
• UDI-Public: (01)00643169077676
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A7523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 05/05/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 115