BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3083561 · Received April 29, 2013

    Report

    Report Number
    2032227-2013-01573
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2010-83224.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT SHE WAS IN A COMA FOR THREE AND A HALF MONTHS BECAUSE THE INSULIN PUMP DELIVERED 19 UNITS OF INSULIN WHILE SHE SLEPT. THE CUSTOMER HAS LOST ALL MEMORY, AND IS NO LONGER ABLE TO WORK. THE CUSTOMER STATED HER LIFE HAS COMPLETELY CHANGED SINCE THAT INCIDENT, AND IS VERY UNHAPPY WITH MEDTRONIC. SHE STATED THAT HER HUSBAND WANTS TO DIVORCE HER DUE TO HER INABILITY TO DO THINGS. THE CUSTOMER STATED SHE HAS UNDERGONE THERAPY AS WELL. THE CUSTOMER HAD CALLED TO REPORT THIS ISSUE PREVIOUSLY, AND WAS CALLING TO FIND OUT WHAT WAS BEING DONE AS SHE HAD NOT HEARD FROM ANYONE. ADVISED THAT HER CONCERNS WOULD BE FORWARDED TO THE LEGAL DEPARTMENT. THE CUSTOMER IS NO LONGER USING THE INSULIN PUMP THAT SHE EXPERIENCED THE ISSUE WITH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184145 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization