BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3200275 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02666
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    November 25, 2012
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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

    A PHONE CALL WAS MADE TO THE CUSTOMER IN ORDER TO FOLLOW UP ON A PREVIOUS CALL SHE HAD MADE FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS TREATED BY THE PARAMEDICS AFTER EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS INITIALLY TREATED AT HOME WITH GLUCAGON, BUT THAT DID NOT WORK, AND THE PARAMEDICS HAD TO BE CALLED. THE CUSTOMER ALSO STATED THAT SHE WAS TREATED BY THE PARAMEDICS ON (B)(6) 2012 DUE TO A HIGH BLOOD GLUCOSE OF 542 MG/DL. THE CUSTOMER DID NOT HAVE ANY FURTHER INFORMATION ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300088 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization