BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945067 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87738
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL WHICH WAS TREATED AND THE CUSTOMER WAS FEELING OKAY. SINCE THE CUSTOMER HAD ALREADY CHANGE THE INFUSION SET NO TROUBLESHOOTING WAS PERFORMED DURING THE PHONE CALL. THE CUSTOMER WAS CALLING ONLY TO FIND OUT WHY THE ALERT OCCURRED AND INFORMATION WAS PROVIDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421224 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR