BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082762 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01077
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THAT SHE WAS EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 555 MG/DL. THE CUSTOMER TREATED WITH A BOLUS, BUT HER BLOOD GLUCOSE LEVELS REMAINED ELEVATED. THE CUSTOMER WAS NOT FEELING WELL AT THE TIME OF THE CALL. THE CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION, AND SHE STATED THAT SHE WOULD BE GOING TO THE HOSPITAL. 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-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization