BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2190302 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01767
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN 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 CALLED IN TO REPORT HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER WAS HAVING DIFFICULTY UNDERSTANDING THE TROUBLESHOOTING. THE PARAMEDICS WERE CALLED FOR THE CUSTOMER, BUT SHE WAS NOT TREATED. BY THE TIME THE PARAMEDICS ARRIVED, HER BLOOD GLUCOSE LEVELS HAD DROPPED DRASTICALLY. THE CUSTOMER DECLINED TROUBLESHOOTING AS HER BLOOD GLUCOSE LEVELS DID GO DOWN AFTER SHE CHANGED THE INFUSION SET. 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-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization