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

Model Number	MMT-523RNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2015
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.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.
Event or Problem Description
It was reported via phone call that the customer has damaged her insulin pump.The customer¿s blood glucose level was unknown at the time.Customer stated she dropped the device in the pool, and water had gotten under the lcd screen and into the reservoir.Customer noted damage to the device from cracks on the corner of the screen to the battery cap.No troubleshooting was performed.Customer was advised a replacement insulin pump would be sent out.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Findings: motor error alarm during the basic occlusion test due to faulty force sensor resistor.Pump passed displacement test, self test and unexpected alarm error test.Pump passed all operating currents tested within the spec range and passed off no power test.Pump was monitored and tested with no audio/beep anomaly noted.Pump received with moisture damage on electronics assembly, cracked battery tube thread, broken reservoir tube lip, cracked case near display window corners, cracked on display window and minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• 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: 6826078
• Report Number: 2032227-2017-41681
• Device Sequence Number: 1601011
• Product Code: OYC
• UDI-Device Identifier: 00643169476486
• UDI-Public: (01)00643169476486
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/25/2017

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A0523RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 130