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

Model Number	MMT-523NAP
Health Effect - Clinical Code	Death (1802)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported that the customer passed away at home.The customer was hospitalized before passing away due to a broken hip.The cause of death was renal failure.The caller stated that the customer had a broken hip that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The pump had been disconnected greater than 48 hours prior to passing.The customer was disconnected as they were overdosed or given too much insulin with insulin twice while in the hospital for the broken hip.The customer was not using sensors.The caller declined to return the insulin pump for analysis.
Additional Manufacturer Narrative
Unit received with depleted energizer alkaline battery installed.Unit passed the displacement test, rewind, basic occlusion test, self test and unexpected restart error test.The stop (idle) current and run current measurement tests are within specification.Unit also passed off no power alarm test and delivery accuracy test.Unit was unable to prime during prime test.Unable to determine root cause of prime anomaly due to pump preservation.Unable to perform the occlusion test and excessive no delivery test due to prime anomaly.Unit had minor scratched display window, cracked case at display window corner, cracked battery tube threads, cracked reservoir tube, cracked reservoir tube window and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 6796179
• Report Number: 2032227-2017-37011
• Device Sequence Number: 136844
• Product Code: OYC
• UDI-Device Identifier: 00613994743879
• UDI-Public: (01)00613994743879
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A3523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Weight: 140