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

Model Number	MMT-722NAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2017
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 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 had compromised force sensor system alarm.The customer's blood glucose level was 136 mg/dl at the time of incident.The customer reported that the insulin pump was not dropped prior to the alarm.The customer was advised to discontinue use of the insulin pump and revert to back up plan.The customer was advised that the insulin pump will need to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump was unable to prime during prime test and a33 test due to faulty force sensor resistor.There was no a33 alarm on the device.The insulin pump passed the basic occlusion test and displacement test.The device was unable to perform the occlusion test and no delivery test due to prime anomaly.The drive support disk was inspected and functioned properly.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB
• 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: 6949918
• Report Number: 2032227-2017-58647
• Device Sequence Number: 891846
• Product Code: OYC
• UDI-Device Identifier: 00613994373113
• UDI-Public: (01)00613994373113
• 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): 09/28/2018

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A4722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 10/08/2017
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 145