BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2090955 · Received May 3, 2011

    Report

    Report Number
    2032227-2011-01145
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTORNIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 500 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET TWICE ON THE DAY OF THE EVENT. THE CUSTOMER HAD ALSO BEEN VOMITING. THE MOTHER REQUESTED TRAINING FOR THE UPGRADED INSULIN PUMP THE CUSTOMER HAD JUST RECEIVED. ADVISED THE MOTHER THAT THE INSULIN PUMP TRAINER WOULD BE CONTACTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTORNIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization