MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAB
Health Effect - Clinical Code	Death (1802)
Date of Event	01/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Pump passed all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, unexpected alarm error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test and excessive no delivery test.However the drive support cap is flush.Pump received with no battery installed.Pump received with partially broken reservoir tube lip, cracked battery tube threads, cracked reservoir tube, cracked reservoir tube window, missing end cap sticker, stained back address label, broken belt clip slot and minor scratched lcd window.Data analysis: there is no data listed for the dated of 01/6/2018 due to pump received without battery installed.
Event or Problem Description
It was reported that the customer passed away in a hospital.The customer was hospitalized on (b)(6) 2017.The cause of death was heart failure.The caller stated that the customer had arthritis 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 more than 48 hours prior to passing, as the nurses used manual injections on the customer.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.The pump was received with a flush drive support cap.
Additional Manufacturer Narrative
Initial report or supplemental report had the incorrect aware date.The correct aware date is (b)(4) 2018.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• 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: 7491449
• Report Number: 2032227-2018-02933
• Device Sequence Number: 1313838
• Product Code: OYC
• UDI-Device Identifier: 00613994748850
• UDI-Public: (01)00613994748850
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2019

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-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A000168173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 262