MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/18/2017
Type of Reportable Event	Malfunction
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
It was reported that the self test failed on the insulin pump.The insulin pump will return.The customer's blood sugar is 277 mg/dl.
Additional Manufacturer Narrative
Failed self-test alarm during self test due to faulty radio frequency board.Pump passed idle current test, run current test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test and rewind test.Unable to perform bg meter test due to failed self-test alarm.The insulin pump was received with minor scratched display window, partially broken off reservoir tube lip, cracked belt clip slot and cracked reservoir tube.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• 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: 6712718
• Report Number: 2032227-2017-28450
• Device Sequence Number: 1003182
• Product Code: OYC
• UDI-Device Identifier: 00613994312389
• UDI-Public: (01)00613994312389
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/14/2017

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: A3722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/18/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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
• Patient Weight: 223