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

Model Number	MMT-523LNAP
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/19/2019
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 that the customer experienced hyperglycemia as well as diabetic ketoacidosis.The customer¿s blood glucose level was over 400 mg/dl, 440 mg/dl at time of incident and current blood glucose level was 153 mg/dl, 161 mg/dl.Customer reports the following symptoms related to their high blood glucose such as really sick and threw up.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer treated with insulin pump for high blood glucose.Customer reports they did not contact their health care professional regarding the high blood glucose.Customer did not allege possible insulin pump was under delivery.Customer states the drive support cap appears normal.Customer was able to perform high pressure test at that time.Customer reports they performed the high pressure test and full 5 units went through but no alarm.Customer reports they repeated high pressure test and went through 5 units no alarm and no insulin came out of tubing.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP
• 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: 8277142
• Report Number: 3004209178-2019-48203
• Device Sequence Number: 1516444
• Product Code: OYC
• UDI-Device Identifier: 00643169932975
• UDI-Public: (01)00643169932975
• 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
• Report Date (Section B): 01/25/2019

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-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Device Lot Number: A5523LNAPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2019
• Initial Report FDA Received Date: 01/25/2019
• 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-MMT-326A- RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Weight: 59