BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4252118 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-37698
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL MEDWATCH REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE INSULIN PUMP PASSED DELIVERY VOLUME ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST. THE INSULIN PUMP WAS RECEIVED WITH AN ENERGIZER ALKALINE BATTERY, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS. THE DOWN LOAD HISTORY FILE BEGINS WITH A RESET ERROR ALARM, FOLLOWED BY NINE ALARMS FOR A CORRUPTED HISTORY FILE, A MEMORY ALARM AND ANOTHER RESET ERROR ALARM ON JANUARY 1, 2008. THE DAILY TOTAL FOR JANUARY 1, 2008 THROUGH JANUARY 22, 2015 WAS 0.0 UNITS OF INSULIN. NO DATA WAS LISTED FOR THE DATE OF SEPTEMBER 23, 2014. THE INSULIN PUMP WAS RESET TO THE FACTORY DEFAULT. THE INSULIN PUMP WAS MONITORED FOR 24 HOURS WITH NO ERROR ALARMS. HOWEVER, THE INSULIN PUMP HAD AN ALARM IN THE ALARM HISTORY DUE TO CORRUPTED HISTORY FILES.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS PROVIDED IN RESPONSE TO YOUR REQUEST DATED (B)(4) 2014 FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS UNCERTAIN BUT IT WAS REPORTED THAT IT WAS LIKELY DUE TO DIABETES. IT WAS REPORTED THAT THE CUSTOMER ALSO WORE A PACEMAKER. IT WAS ALSO REPORTED THAT NO AUTOPSY WAS DONE AND THAT THE CUSTOMER HAD BEEN FOUND IN THE BATHROOM. NO BLOOD GLUCOSE READING WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. HIS OR HER BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF PASSING. IT IS UNKNOWN WHETHER THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF DEATH OR IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738007 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LCMS

    Patients

    Seq Age Sex Outcome Treatment
    1