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

Model Number	MMT-523NAS
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/20/2017
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 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
Customer called and reported that they experienced low blood glucose on (b)(6) 2017 with blood glucose of 43 mg/dl at the time of the incident.The customer was at 163 mg/dl at the time of the call.The customer was wearing the insulin pump during the incident.Troubleshooting was completed and the customer believes the pump over delivered insulin.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit received with a motion sensor test failure alarmed during rewind due to motor encoder signal out of phase.Unable to perform operating currents, self-test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test or verify possible over delivery due to the motion sensor test failure alarms.Pump received with minor scratched lcd window, cracked belt clip slot and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 7155944
• Report Number: 2032227-2017-78576
• Device Sequence Number: 1213288
• Product Code: OYC
• UDI-Device Identifier: 00643169693760
• UDI-Public: (01)00643169693760
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/08/2018

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B5523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 05/08/2018
• 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: 77 YR
• Patient Weight: 161