BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190405 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01839
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS, AND HAD NOT CHANGED THE INFUSION SET TO SOLVE THE ISSUE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NOT TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER COULD NOT VERIFY THE INSULIN PUMP SETTINGS AS SHE HAD NOT SEEN HER DOCTOR IN OVER A YEAR. THE CUSTOMER DID GET A NO DELIVERY ALARM ON THE DATE OF THE HOSPITALIZATION. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization