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	04/04/2017
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 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
It was reported via phone call that they had received a motor error alarm and had a loose drive support cap.The customer's blood glucose level was unknown.The device will be returned for analysis.
Additional Manufacturer Narrative
Findings: pump received with stuck motor error alarm loop during bolus delivery.The motor was tested outside the device and passed.Motor may have had an intermittent failure that was not detected during testing.Unable to perform occlusion test and unexpected alarm error test due to motor error alarms.Pump passed displacement test, rewind test, basic occlusion test, prime test and self test.Pump passed all operating currents tested within the spec range and passed off no power test.Pump received with corroded battery tube, cracked reservoir tube lip, peeling address/serial number label, cracked case near display window corners, cracked on display window and minor scratches on display window noted.Drive support cap was inspected and no anomaly was noted.

• 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: 6606420
• Report Number: 3004209178-2017-51567
• Device Sequence Number: 797485
• Product Code: OYC
• UDI-Device Identifier: 00643169478510
• UDI-Public: (01)00643169478510
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: B3722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1