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

Model Number	MMT-722RNAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/29/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit did not have a battery installed when received.Unit passed the displacement test, rewind, self test and unexpected restart error test.All operating currents are within specification.Off no power alarm functions properly.Unit was unable to prime during prime/compromised force sensor system test and alarmed motor error during basic occlusion test due to faulty fsr (gold).The motor was tested outside of the unit and passed.Unable to perform the occlusion test, excessive no delivery test and the delivery accuracy test due to prime anomaly.Unit had intermittent button response on the express bolus and up arrow buttons due to corroded keypad traces.No button error alarm noted.During visual inspection, the j2 keypad connector on the lcd/b was found locked properly.Unit uploaded properly using carelink.Unit had cracked case at display window corner, cracked battery tube threads, cracked belt clip slot, cracked reservoir tube, cracked reservoir tube window, scratched reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Here is no data available due to the unit did not have a battery installed when received.(b)(4).
Event or Problem Description
It was reported via phone call that the customer passed away in an unknown location.The cause of death was not provided.The caller stated that the customer had coronary pulmonary issues and diabetes that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The caller declined to provide further information.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.The caller did not state whether they would return the insulin pump for analysis, but unexpectedly returned it.This report was made for the failure analysis results.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS
• 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: 10383406
• Report Number: 2032227-2020-159876
• Device Sequence Number: 19301530
• Product Code: OYC
• UDI-Device Identifier: 00613994623935
• UDI-Public: (01)00613994623935
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2020

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-722RNAS
• Device Catalogue Number: MMT-722RNAS
• Device Lot Number: A000142622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: 77 YR
• Patient Weight: 92