MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAH
Health Effect - Clinical Code	Death (1802)
Date of Event	04/04/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The asr exemption e2015043 was revoked on (b)(6) 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr the unit did not have a battery installed when received.Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test and excessive no delivery test.No button error alarm noted.Unit had intermittent button response.Unable to determine root cause of intermittent button response due to pump preservation.Unit had minor scratched display window, scratched case, broken battery tube threads, cracked reservoir tube, cracked reservoir tube window, cracked reservoir tube lip and a stained end cap sticker.Data analysis: there is no data available due to the unit did not have a battery installed when.Unit passed the delivery volume accuracy test 99.96 % accuracy.After the dva test was completed, the keypad was inspected, and the intermittent button response was due to corroded keypad traces.
Event or Problem Description
It was reported via phone call that the customer passed away in an unknown location.The cause of death was unknown.The caller did not know if 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.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 original owner of the pump had passed and the pump was gifted to the caller.The caller agreed to return the insulin pump for analysis.This report was created for the analysis results.The keypad was inspected and the intermittent button response was due to corroded keypad traces.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 10659747
• Report Number: 2032227-2020-189113
• Device Sequence Number: 11388827
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• 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): 10/09/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A6723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/09/2020
• 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: 63 YR
• Patient Weight: 57