BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2133673 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01400
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 580 MG/DL. THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST FEW DAYS. THE CUSTOMER HAS BOLUSED, BUT HER BLOOD GLUCOSE LEVELS REMAINED ELEVATED. THE CUSTOMER HAS ALSO HAD BENT CANNULAS, BUT HAS NOT REC'D ANY ALARMS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-399, LOT 9200612