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

Model Number	MMT-523NAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
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
The customer reported via phone call the insulin pump would not exit the preparing to prime loop and insulin squirted out of the tubing during manual prime.The customer¿s blood glucose was 230 mg/dl at the time of the incident.During troubleshooting, the insulin pump was unable to exit the priming process.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 device alarmed motor error during the basic occlusion test due to loose and protruded drive support disk.We were unable to confirm prime and fill anomaly due to motor error alarm.The insulin pump passed all operating currents tested within the specification range; it passed off no power test, displacement test, self test and unexpected restart error test.The insulin pump was received with cracked battery tube thread, cracked reservoir tube lip, cracked reservoir tube, cracked case near display window corners, cracked on display window, missing end cap sticker and minor scratches on display window noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 6568253
• Report Number: 3004209178-2017-51126
• Device Sequence Number: 18858364
• Product Code: OYC
• UDI-Device Identifier: 00613994743855
• UDI-Public: (01)00613994743855
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/12/2017

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: A3523NAHJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 150