BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAB

    MDR report key: 9694404 · Received February 11, 2020

    Report

    Report Number
    2032227-2020-101087
    Event Type
    Death
    Date Received
    February 11, 2020
    Date of Event
    November 16, 2019
    Report Date
    February 11, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    00613994623898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH A DEPLETED (B)(6) ALKALINE BATTERY INSTALLED. UNIT HAD A BLEEDING LCD GLASS. UNIT PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DAT TEST AT 0.08725 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. UNIT ALSO PASSED OFF NO POWER ALARM TEST AND A21 ERROR TEST. UNIT UPLOADED PROPERLY USING CARELINK. UNIT ALSO HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW, MISSING END CAP STICKER AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 86.300U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 88.200U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 85.000U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 80.300U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 85.650U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 74.300U, (B)(6) 2019 00:00:00 DAILY INSULIN TOTAL = 25.750U.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN THE HOSPITAL ON (B)(6) 2019. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2019 AND PRONOUNCED DECEASED THERE. THE CAUSE OF DEATH WAS REPORTED AS DIABETES, HEART FAILURE AND RENAL FAILURE. THE CALLER STATED THAT THE CUSTOMER HAD HEART AND RENAL FAILURE AS WELL AS ADDISON'S DISEASE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF PASSING. THE CUSTOMER WAS USING A THIRD PARTY'S SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THIS CASE IS ONLY BEING REPORTED FOR THE MALFUNCTION DISCOVERED IN FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156281 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-722RNAB A000142613 00613994623898

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death