BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4130180 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24508
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    DURING A F/U PHONE CALL, IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AGO THE INSULIN PUMP LOCKED OUT AND ALL OF THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER COULD NOT RECALL THEIR BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT AND THEY COULD NOT RECALL IF THE DEVICE WAS FROZEN AND/OR IF IT HAD A BLANK DISPLAY. THE CUSTOMER HAD CHANGED THE BATTERY WHICH SOLVED THE ISSUE. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS 72 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578994 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR