MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722RNAB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/16/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Unit received with a depleted (b)(6) alkaline battery installed.Unit had a bleeding lcd glass.Unit passed the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat test at 0.08725 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed off no power alarm test and a21 error test.Unit uploaded properly using carelink.Unit also had minor scratched display window, cracked battery tube threads, scratched reservoir tube window, missing end cap sticker and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: (b)(6) 2019 00:00:00 daily insulin total = 86.300u, (b)(6) 2019 00:00:00 daily insulin total = 88.200u, (b)(6) 2019 00:00:00 daily insulin total = 85.000u, (b)(6) 2019 00:00:00 daily insulin total = 80.300u, (b)(6) 2019 00:00:00 daily insulin total = 85.650u, (b)(6) 2019 00:00:00 daily insulin total = 74.300u, (b)(6) 2019 00:00:00 daily insulin total = 25.750u.
Event or Problem Description
It was reported via phone call that the customer passed away in the hospital on (b)(6) 2019.The customer was hospitalized on (b)(6) 2019 and pronounced deceased there.The cause of death was reported as diabetes, heart failure and renal failure.The caller stated that the customer had heart and renal failure as well as addison's disease that may have led to the customer's passing.The customer's blood glucose was unknown at the time of death.The customer was wearing the insulin pump at the time of passing.The customer was using a third party's sensors.The caller agreed to return the insulin pump for analysis.This case is only being reported for the malfunction discovered in failure analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9694404
• Report Number: 2032227-2020-101087
• Device Sequence Number: 2422836
• Product Code: OYC
• UDI-Device Identifier: 00613994623898
• UDI-Public: (01)00613994623898
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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-722RNAB
• Device Catalogue Number: MMT-722RNAB
• Device Lot Number: A000142613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: Death
• Patient Age: 72 YR
• Patient Weight: 137