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

Model Number	MMT-523NAH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose.Customer's blood glucose was over 600 mg/dl.Customer reported that the insulin pump had frozen display as well as insulin pump alarmed after battery changed.Customer also reported that they were unable to clear the alarm.Customer stated that an alarm occurred during that time the buttons stopped.Screen was not blank after inserting new battery.Troubleshoot was performed.Customer advised to insulin pump will need to be replaced and revert to back up plan.Insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received no button response (act) due to corroded keypad traces.Insulin pump time clock advances no frozen screen noted.The information provided in the section of concomitant product with the initial report was incorrect.The correct information has been included with this report.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 7892388
• Report Number: 2032227-2018-30647
• Device Sequence Number: 1434359
• Product Code: OYC
• UDI-Device Identifier: 00643169446397
• UDI-Public: (01)00643169446397
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: B2523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 09/02/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN RESERVOIRUNOMEDICAL INFST
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR
• Patient Weight: 61