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

Model Number	MMT-723RNAL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 alarmed and had a blank display before and after a battery change.Customer's blood glucose was 76mg/dl at the time of incident.The product will be returned.
Additional Manufacturer Narrative
Motor error alarm during the basic occlusion test due to faulty force sensor resistor.Pump passed displacement test, self test and unexpected restart error test.The insulin pump passed all operating currents tested within the spec range and passed off no power test.The insulin pump was monitored and tested with no blank display, frozen screen or constant tone noted.The insulin pump was received cracked battery tube thread, cracked reservoir tube lip, cracked case near display window corners,cracked on display window, stained end cap sticker and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 6692684
• Report Number: 2032227-2017-26578
• Device Sequence Number: 2066039
• Product Code: OYC
• UDI-Device Identifier: 00613994904409
• UDI-Public: (01)00613994904409
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000205306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR