MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAS
Health Effect - Clinical Code	Death (1802)
Date of Event	02/24/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Pump passed the idle current measurement test, run current measurement test, self test, off no power test, unexpected alarm error test, displacement test and rewind test.However, motor error alarm during the basic occlusion test and pump unable to prime during the prime test due to loose/protruded drive support disk.Unable to perform the occlusion test, excessive no delivery test and displacement accuracy test due to motor error alarm and pump unable to prime.Unable to perform the motor test due to pump preservation.Pump received with no battery installed.Pump received with cracked reservoir tube lip, stained end cap sticker, stained back address label, scratched reservoir tube window and minor scratched lcd window.Data analysis: the date of death was not specified.There is no data listed due to pump received without battery installed.
Event or Problem Description
It was reported that the customer passed away in an unknown location.The cause of death was unknown, but there was no indication that a medtronic product caused or contributed to the customer's passing.The notifier did not state whether the customer had any illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.It is unknown if the customer was wearing the insulin pump at the time of death.It is unknown if the customer was using sensors.No further information was provided.The pump was returned for analysis.The pump alarmed motor error alarm during the basic occlusion test, and the pump was unable to prime during the prime/a33 test due to loose/protruded drive support disk.
Additional Manufacturer Narrative
Initial report or supplemental report had the incorrect aware date.The correct aware date is (b)(6) 2018.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 7491296
• Report Number: 3004209178-2018-69581
• Device Sequence Number: 145138
• Product Code: OYC
• UDI-Device Identifier: 00613994373083
• UDI-Public: (01)00613994373083
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A4722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 113