BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS

    MDR report key: 16360807 · Received February 13, 2023

    Report

    Report Number
    2032227-2023-157701
    Event Type
    Death
    Date Received
    February 13, 2023
    Date of Event
    August 23, 2021
    Report Date
    February 13, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169513143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION. (B)(4). S/W 3.0B. ON AUGUST 23, 2021 THE CUSTOMER PASSED AWAY. UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DAT AT 0.0874 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. UNIT ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. UNIT RECEIVED WITH A DEPLETED ENERGIZER INDUSTRIAL ALKALINE BATTERY INSTALLED. PLEASE SEE BELOW WHEN REVIEWING THE HISTORY DOWNLOAD. THERE IS NO DATA AVAILABLE DUE TO THE UNIT RECEIVED WITH A DEPLETED BATTERY INSTALLED. UNIT PASSED THE FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT HARM REPORTED, WITH NO ALLEGATION OCCURRED. THERE WAS AN ALLEGATION OF DEATH AS A RESULT OF THIS EVENT. FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517159 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS A1723RNASJ 000000643169513143

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death