BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2020714 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00569
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS OVER 800 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. WHEN THE INFUSION SET WAS REMOVED FROM THE CUSTOMER'S BODY, IT WAS DISCOVERED THAT THE CANNULA WAS BENT. THE CUSTOMER USES QUICK-SET INFUSION SETS, MODEL NUMBER MMT-396. PRIOR TO THE EVENT, THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER ATTEMPTED MULTIPLE INFUSION SET CHANGES TO RESOLVE THE HIGH BLOOD GLUCOSE LEVELS. 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-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization