BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2090915 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01110
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED BY THE CUSTOMER'S ATTORNEY: IN 2002, CUSTOMER'S DOCTOR PRESCRIBED THE USE OF AN INSULIN PUMP AND INFUSION SET. SOMETIME THEREAFTER, CUSTOMER FAILED TO RECEIVE THE CORRECT DOSE OF INSULIN TO MANAGE HER DIABETIC CONDITION. CONSEQUENTLY, SHE WAS HOSPITALIZED NUMEROUS TIMES, AND IT IS ALLEGED SHE EVENTUALLY HAD KIDNEY FAILURE AND KIDNEY AND PANCREAS TRANSPLANTS RESULTING FROM IMPROPER AMOUNTS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP FRN MEDTRONIC MINIMED MMT-511USC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization