BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2112308 · Received May 24, 2011

    Report

    Report Number
    2032227-2011-01302
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    March 3, 2011
    Report Date
    May 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT LOW BATTERY LIFE. THE CUSTOMER ALSO STATED THAT SHE WAS HOSPITALIZED DUE TO SEPTIC SHOCK AND ACUTE KIDNEY INJURY. IT WAS UNK WHETHER OR NOT THE EVENT WAS DIABETES RELATED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WITH LOW BATTERY LIFE WERE NOT RESOLVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization