BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021589 · Received March 8, 2011

    Report

    Report Number
    2032227-2011-00616
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 500 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. THE CUSTOMER STATED THAT SHE SOMETIMES HAS PAIN AS IF SHE IS HAVING A HEART ATTACK. THE CUSTOMER STATED THAT THE PARAMEDICS WENT TO HER HOME LAST NIGHT BUT SHE REFUSED TO GO TO THE HOSPITAL. THE CUSTOMER WAS ADVISED BY HER HEALTHCARE PROFESSIONAL TO CHANGE HER BASAL RATES, BUT THE CUSTOMER DID NOT CHANGE THEM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR