MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hyperglycemia (1905)
Date of Event	07/11/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.The unit did not have a battery installed when received.Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat test at 0.08730 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and a21 error test.Unit uploaded properly using carelink.Unit had cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: 07/14/20 00:00:00 daily insulin total = 28.375u, 07/15/20 00:00:00 daily insulin total = 0.000u, 07/16/20 00:00:00 daily insulin total = 0.000u, 07/17/20 00:00:00 daily insulin total = 0.000u, 07/18/20 00:00:00 daily insulin total = 0.000u, 07/19/20 00:00:00 daily insulin total = 0.000u, 07/20/20 00:00:00 daily insulin total = 0.000u.
Event or Problem Description
It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2020 for high blood glucose.The cause of death was sepsis.The caller stated that the customer had many high blood glucose incidents that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of hospitalization and passing.The customer was wearing the insulin pump at the time of hospitalization.The insulin pump had been disconnected more than 48 hours prior to passing, due to other medical complications.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• 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; * 00777-3869
• MDR Report Key: 10460769
• Report Number: 2032227-2020-169294
• Device Sequence Number: 2171412
• Product Code: OYC
• UDI-Device Identifier: 00643169513143
• UDI-Public: (01)00643169513143
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A1723RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Weight: 155