MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The insulin pump was received with broken battery tube thread, 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 and minor scratches on display window noted.The test reservoir does not stay locked in place due to reservoir tube lip damage.
Event or Problem Description
The customer reported via phone call that the insulin pump was damaged.The customer¿s blood glucose level was unknown at the time of the incident.The customer reported that the plastic at the top of the reservoir broke and is unable put the reservoir in there anymore.The customer did not troubleshoot the issue.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be 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-523LNAL
• 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: 6891832
• Report Number: 2032227-2017-52391
• Device Sequence Number: 706031
• Product Code: OYC
• UDI-Device Identifier: 00643169479616
• UDI-Public: (01)00643169479616
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/03/2017

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A3523LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 09/19/2016
• Supplement Date Received by Manufacturer: 08/11/2016
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 66