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

Model Number	MMT-723LNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
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
Customer reported that the reservoir was damaged and the o-ring was coming out.Customer's blood glucose value was unknown.Customer was advised to discontinue use of the pump and revert to a back-up plan per healthcare professional¿s instruction.Insulin pump will be returned for analysis and a replacement pump will be sent.
Additional Manufacturer Narrative
Insulin pump received with cracked battery tube thread, broken belt clip slot, reservoir tube lip completely broken off, missing reservoir tube lip o-ring, cracked reservoir tube, cracked reservoir tube window, cracked case near display window corners, cracked on display window, stained end cap sticker and minor scratches on display window noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 7187007
• Report Number: 3004209178-2018-43067
• Device Sequence Number: 16437489
• Product Code: OYC
• UDI-Device Identifier: 00643169478572
• UDI-Public: (01)00643169478572
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/15/2018

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-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A4723LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 141