BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4100795 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23460
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REQUESTING ASSISTANCE IN FILLING UP THE RESERVOIR OF THE INSULIN PUMP. HOWEVER DURING THE COURSE OF THE TELEPHONE CONVERSATION, THE CUSTOMER SUDDENLY FELT DIZZY. FORTUNATELY THE CUSTOMER HAD A COMPANION AT THAT TIME THAT ASSISTED CUSTOMER IN CALLING 911. THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE LEVELS OF 35 MG/DL. THE CUSTOMER REPORTED BEING TREATED BY THE AMBULANCE PERSONNEL WITH A GLUCAGON SHOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572061 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR