MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAS
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/03/2017
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 alarmed button error.The customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump alarmed button error and the numbers ramp up while trying to deliver a bolus.Button error troubleshooting was performed and confirmed that time is advancing.Customer also reported that she had an insulin reaction and paramedics came out and she was treated with glucose.Customer reported that she gave too much insulin that resulted in low blood glucose.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
Unit received with button error alarm and had unresponsive up button due to corroded keypad traces.No unexpected numbers ramping/scrolling during testing.Unit had minor scratched lcd window, cracked lcd window, cracked battery tube threads, cracked reservoir tube lip, cracked case at display window corners, cracked reservoir tube, cracked reservoir tube window, cracked case at reservoir tube window corners, stained address / serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7031590
• Report Number: 2032227-2017-65813
• Device Sequence Number: 2144118
• Product Code: OYC
• UDI-Device Identifier: 00613994748706
• UDI-Public: (01)00613994748706
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/18/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000167945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 162