BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2039125 · Received March 24, 2011

    Report

    Report Number
    2032227-2011-00763
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT SHE HAD A SEIZURE PRIOR TO BEING ADMITTED. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 500 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. THE INFUSION SET BEING WORN AT THE TIME OF THE EVENT WAS AN MMT-397, LOT #9201723. 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-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization