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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/07/2011
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit was received without battery.Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test and the excessive no delivery test.Unit had unexpected vibrator noise during vibrate check.Unable to determine vibrator anomaly due to pump preservation.Ab 06-28-11; gm 6-29-11 unit had unexpected vibrator noise during vibrate check due to adhesive not adhering the vibrator motor to the case.(b)(4).
Event or Problem Description
The customer's wife was reported via phone call that the customer passed away in an unknown location.The cause of death was severe cardiac arrest.The caller did not state whether the customer had any other illnesses 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 insulin pump had been disconnected more than 48 hours prior to passing.It is unknown if the customer was using sensors.The caller agreed to return the insulin pump for analysis.Pump had unexpected vibrator noise during vibrate check due to adhesive not adhering the vibrator motor to the case.This report was created for the failure analysis results.

• 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; * 00777-3869
• MDR Report Key: 10689332
• Report Number: 2032227-2020-192149
• Device Sequence Number: 16987148
• Product Code: OYC
• UDI-Device Identifier: 00613994271402
• UDI-Public: (01)00613994271402
• 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
• Report Date (Section B): 10/16/2020

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A2722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2011
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 72