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

Model Number	MMT-523NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/14/2017
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 via phone call that the insulin pump was not delivering insulin.They were not receiving any alerts or no delivery alarms.The customer's blood glucose level was 374 mg/dl.Troubleshooting was performed.They were sent a tubing clamp and was advised to call back to run the high-pressure test.It was noted that the customer had called back.They performed the high-pressure test.The insulin pump did not alarm a no delivery in less than 5.0 units.The customer also reported that they had a motor error alarm.The customer was able to complete the insulin pump rewind.The customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
The insulin pump was received with operating currents within spec.Unit passed basic occlusion test and displacement test.However, unable to prime unit during prime test due to slightly loose drive support disk.Unable to perform occlusion test, excessive no delivery test or verify motor error alarms due to prime anomaly.The motor was tested outside the device and passed.The insulin pump was received with cracked case at the display window corners, reservoir tube lip, reservoir tube window corners and battery tube threads.Unit received with minor scratched display window and case.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 6701599
• Report Number: 2032227-2017-27391
• Device Sequence Number: 19092397
• Product Code: OYC
• UDI-Device Identifier: 00613994743862
• UDI-Public: (01)00613994743862
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/02/2017

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A3523NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 174