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	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received with missing segment/partial display, problem isolated to lcd board.The insulin pump had minor scratched lcd window, cracked case, cracked lcd window, broken battery tube threads, cracked reservoir tube lip, cracked case at display window corners, cracked case at reservoir tube window corners, stained address/serial number label and missing end cap sticker.The insulin pump was received without original battery cap.Unable to verify damage to the original battery cap.
Event or Problem Description
Customer reported via phone call for cosmetic damage.Blood glucose was unknown.The customer also reported that the insulin pump was taped together.Customer reported that her battery cap was broken and there are cracks above the screen.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
The aware date provided with the initial report was incorrect.The correct information has been provided with this report.

• 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: 7441175
• Report Number: 3004209178-2018-65957
• Device Sequence Number: 16434294
• 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): 04/30/2018

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: 01/10/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 150