BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2161774 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01670
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 734 MG/DL. THE CUSTOMER EXPERIENCED EVALUATED BLOOD GLUCOSE LEVELS, EXCESSIVE THIRST AND VOMITING PRIOR TO THE EVENT. IT WAS ALSO STATED THAT THE CUSTOMER HAD BEEN GETTING MULTIPLE NO DELIVERY ALARMS FOR THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. FOUND THAT THE CUSTOMER HAS ALSO EXPERIENCED BENT CANNULAS. THE CUSTOMER STATED THAT SHE DOES NOT ROTATE HER INSERTION SITES, AND NORMALLY INSERTS IN THE SAME GENERAL AREA. ADVISED THE CUSTOMER TO ROTATE TO DIFFERENT AREAS TO MINIMIZE SCAR TISSUE. 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-712RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-397