BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193392 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01883
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2009
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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'S OFFICE: IN (B)(6) 2007, CUSTOMER'S DR PRESCRIBED THE USE OF AN INSULIN PUMP AND INFUSION SET. IN 2009, THE CUSTOMER HAD SEVERAL HOSPITALIZATIONS WHEN HE FAILED TO RECEIVED THE CORRECT DOSES OF INSULIN TO MANAGE HIS DIABETIC CONDITION. HE SUFFERED HYPOGLYCEMIA AND HYPERGLYCEMIA RESULTING FROM IMPROPER AMOUNTS OF INSULIN. AS A DIRECT AND PROXIMATE RESULT, HE HAS SUFFERED AND WILL CONTINUE TO SUFFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization