BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3972377 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05167
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER'S MOTHER CALLED IN TO REPORT THAT HER DAUGHTER WAS RECEIVING A NO DELIVERY ALARM FROM HER PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 216 MG/DL. THE CUSTOMER'S MOTHER SAID THAT THE EVENT OCCURRED WHEN HER DAUGHTER WENT TO BOLUS FOR DINNER AND AFTER THE PUMP GAVE HER TWO OUT OF THREE INSULIN UNITS IT ALARMED NO DELIVERY. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE NO DELIVERY ALARM AND EXPLAINED THAT SHE WOULD JUST LIKE TO DO A COMPLETE SET CHANGE. WE ADVISED THE CUSTOMER TO CONTACT US IF THE ISSUE WITH HER INSULIN PUMP PERSISTS. WE EXPLAINED THAT SHE MAY DELIVER THE REMAINING UNIT OF INSULIN AFTER THE SET CHANGE IF IT WAS STILL NEEDED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447649 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR