BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090914 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01109
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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: LAWSUIT ALLEGES, IN 2009, CUSTOMER'S DOCTOR PRESCRIBED AN INSULIN PUMP AND INFUSION SET. CUSTOMER ALLEGEDLY FAILED TO RECEIVE THE CORRECT DOSES OF INSULIN TO MANAGE HER DIABETIC CONDITION AND HAD A SEIZURE. ONE MORE TIME IN 2009 SHE FAILED TO RECEIVE THE CORRECT DOSE OF INSULIN TO MANAGE HER DIABETIC CONDITION, FELL AND WAS HOSPITALIZED. BOTH INCIDENTS ARE ALLEGED TO HAVE BEEN THE RESULT OF IMPROPER AMOUNTS OF INSULIN PRESUMABLY RELATED TO ISSUES WITH THE INSULIN PUMP AND/OR INFUSION SET. AS A RESULT OF THE ALLEGED ISSUES WITH THE PUMP AND/OR INFUSION SET, SHE HAS SUFFERED DAMAGES.

    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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization