MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2015
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 via phone call that the insulin pump button stop working.Customer did not recall blood glucose at the time of incident.Customer cannot recall the cause of the issue.Troubleshoot was not performed.The insulin pump will not be returning for analysis.
Additional Manufacturer Narrative
The insulin pump had blank display due to moisture damage on electronics.Unable to perform idle current test, run current test, self test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to blank display.The insulin pump was received with severely scratched display window, cracked battery tube threads, cracked reservoir tube lip, cracked belt clip slot, cracked reservoir tube and cracked reservoir tube window.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6621807
• Report Number: 3004209178-2017-53633
• Device Sequence Number: 13684579
• Product Code: OYC
• UDI-Device Identifier: 00613994402110
• UDI-Public: (01)00613994402110
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/31/2017

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A5522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 170