BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2021563 · Received March 8, 2011

    Report

    Report Number
    2032227-2011-00605
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS IN THE PAST, BUT WAS UNABLE TO PROVIDE THE DATE OR ANY INFORMATION REGARDING THE EVENT. THE CUSTOMER WAS FEELING NAUSEOUS, IRRITABLE AND FELT LIKE VOMITING AT THE TIME OF THE CALL. THEREFORE, NO TROUBLESHOOTING WAS CONDUCTED. ADVISED TO MONITOR HER BLOOD GLUCOSE LEVELS, AND SEEK MEDICAL ATTENTION IF NECESSARY. THE CUSTOMER STATED THAT SHE WOULD BE UPGRADING TO ANOTHER INSULIN PUMP. 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-712LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization