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	08/02/2017
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
It was reported that the customer insulin pump alarmed motor error and unable to rewind.Customer¿s blood glucose was 262 mg/dl at the time of incident.It was also reported that the insulin pump drive support cap was sticking out.No troubleshooting was performed.Insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump was received with motor error alarm during occlusion test due to faulty force sensor resistor (tin).Motor passed motor test.Drive support disk was inspected and no anomaly was noted.Unit was received with cracked case at display window corner, minor scratched lcd window, cracked battery tube threads, cracked belt clip slot at battery tube threads area, cracked reservoir tube lip, and scratched reservoir tube window.

• 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: 6815151
• Report Number: 2032227-2017-39974
• Device Sequence Number: 1420079
• 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): 02/07/2018

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: B3722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1