MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/20/2018
Type of Reportable Event	Death
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 that the customer passed away at home on (b)(6) 2018 due to diabetes and kidney problems.The customer¿s blood glucose was unknown at the time of death, but caller reported that it had gone down as low as 25 mg/dl in the past, but was not sure of the readings at the time of death.The customer was not wearing the insulin pump at the time of death, but it was removed that day.The customer was not using sensors.Caller declined uploading pump into carelink.Caller agreed to return products and it¿s expected to return for failure analysis.
Additional Manufacturer Narrative
Device did not have a battery installed when received.Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using care link.Device had minor scratched display window, cracked battery tube threads, scratched reservoir tube window and cracked reservoir tube lip.Data analysis: (date of customer passing: november 20 2018.) there is no data available due to the unit did not have a battery installed when received.
Additional Manufacturer Narrative
The information provided that the event date with the initial report was incorrect.The correct information has been included with this report.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 9132725
• Report Number: 2032227-2019-70221
• Device Sequence Number: 14233862
• Product Code: OYC
• UDI-Device Identifier: 00643169221543
• UDI-Public: (01)00643169221543
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A000207238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 01/25/2021
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/23/2019; 01/27/2021
• 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-UNK-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR