BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143392 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30030
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLEEDING LCD GLASS AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HAD DISCOLORATION ON THE SCREEN OF THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 50 MG/DL. CUSTOMER TREATED WITH HARD CANDY. CUSTOMER STATED THERE WAS A GRAY CIRCLE TOWARD THE BOTTOM OF THE SCREEN ABOVE THE ESC BUTTON. CUSTOMER REPORTED PHYSICAL DAMAGE TO THE PUMP. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603298 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR