BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123327 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29510
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). PLEASE SEE MEDWATCH REPORT 2032227-2014-27193.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD GONE TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 914 MG/DL. THE CUSTOMER WAS THIRSTY AND THEIR LEGS WERE CRAMPING. THE CUSTOMER STATED THAT, THE WEEK PRIOR TO THE EMERGENCY ROOM VISIT, THEIR BLOOD GLUCOSE HAD BEEN ELEVATED AND THE CANNULA OF THE INFUSION SET WAS KINKED, BUT THE INSULIN PUMP HAD NOT ALARMED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602749 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization