MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/12/2017
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.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's parent reported via phone call that the insulin pump was not functioning properly.They were changing the infusion set when the insulin pump alarmed a motor error and all of the settings were erased.The customer's blood glucose level was 536 mg/dl.The alarm history was reviewed and they found multiple no delivery alarms, multiple motor error alarms, and one motor position encoder error alarm.The customer was advised to discontinue use of the device and revert to a back-up plan.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
The insulin pump alarmed motor error during the basic occlusion test due to faulty force sensor resistor.The motor was tested outside of the device and passed.We were unable to confirm encoder signal alarm due to overwritten history file and unable to confirm excessive no delivery alarms due to motor error alarm.The insulin pump passed displacement test, self-test and unexpected restart error test.The insulin pump passed all operating currents tested within the specification range and passed off no power test.No unexpected resetting or settings anomaly noted.The insulin pump was received with broken battery tube thread, cracked reservoir tube lip, cracked reservoir tube, cracked reservoir tube window, cracked case near display window corners, missing end cap sticker and minor scratches on display window noted.The drive support cap was inspected and no anomaly was noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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: 6696123
• Report Number: 2032227-2017-26894
• Device Sequence Number: 19155366
• Product Code: OYC
• UDI-Device Identifier: 00613994904348
• UDI-Public: (01)00613994904348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: A4723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 07/08/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 16 YR
• Patient Weight: 127