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

Model Number	MMT-522NAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
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
The customer reported that her insulin pump got wet.It was working but when the customer changed the infusion set, the screen is showing black lines and black boxes.Troubleshooting was performed.The insulin pump is flashing numbers, stopping and repeating.The customer was advised to discontinue pump therapy and return the insulin pump.The customer's blood glucose is unknown.
Additional Manufacturer Narrative
The correct information has been provided with this report.Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Additional Manufacturer Narrative
Unit received with blank display due to moisture damaged electronic assembly.Also moisture damage motor during visual inspection.Unable to perform operating current test, error test or all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test or verify black lines, full missing segment or display anomaly due to blank display.Unit had minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, cracked reservoir tube, cracked case at reservoir tube window corners, stained address/serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 6804591
• Report Number: 2032227-2017-37990
• Device Sequence Number: 19349306
• Product Code: OYC
• UDI-Device Identifier: 00613994402127
• UDI-Public: (01)00613994402127
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/30/2018

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-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A5522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 07/22/2017
• Supplement Date Received by Manufacturer: 07/22/2017; 01/19/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/17/2017; 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 81