BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2161742 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01647
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER DID NOT KNOW HER BLOOD GLUCOSE READING AT THE TIME OF ADMISSION. THE CUSTOMER NEEDED ASSISTANCE WITH AN ALARM, AS WELL AS REWINDING THE INSULIN PUMP. ADVISED THE CUSTOMER TO GET CHECKED FOR SCAR TISSUE SINCE SHE WAS CURRENTLY IN THE HOSPITAL. 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-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization