MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/11/2016
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 insulin pump screen was hard to read and the audio does not work.The customer also reported that they were having low blood glucose.The customer's blood glucose was unknown at the time of incident.The customer declined to troubleshoot.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Motor error alarm during the occlusion test and unable to prime during the prime/compromised force sensor system test due to faulty fsr (gold).Pump passed the self test, rewind, basic occlusion test and displacement test.Unable to perform the no delivery test due to motor error alarm.The audio/vibration feature functioned properly.No audio/beep anomaly noted.Pump had minor scratched display window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 7053257
• Report Number: 2032227-2017-67735
• Device Sequence Number: 13720276
• Product Code: OYC
• UDI-Device Identifier: 00613994748744
• UDI-Public: (01)00613994748744
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/17/2018

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000168682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 07/21/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR