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

Model Number	MMT-523RNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/17/2017
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 that the buttons were unresponsive on the insulin pump.The customer's blood glucose was 500 mg/dl at the time of incident.The customer's high blood glucose was treated with a manual injection.The customer also reported the time was able to advance on the insulin pump, but the pump was stuck on rewind during troubleshoot.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit received with no button response due to unlocked j2/lcd keypad connector.No button error alarm noted.Unable to perform self-test, unexpected restart error test, displacement test, rewind, basic occlusion test, occlusion test, operating currents, prime test, off no power test and excessive no delivery test due to no buttons response.Unable to confirm rewind anomaly due to unresponsive buttons.Unit received with cracked reservoir tube lip, minor scratched display window, cracked case at display window corner, cracked belt clip slot, cracked battery tube threads, cracked case and shifted end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 6595894
• Report Number: 3004209178-2017-51239
• Device Sequence Number: 16165881
• Product Code: OYC
• UDI-Device Identifier: 00643169476493
• UDI-Public: (01)00643169476493
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/07/2017

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A0523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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: 74 YR
• Patient Weight: 124