BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183468 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40026
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 IS REPORTED THAT A CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 480 MG/DL. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER CHANGED HIS INFUSION SET AND NOTICED HE HAD A BENT CANNULA. THE CUSTOMER WAS OFFERED TO SPEAK TO THE HELP LINE BUT HE STATED THAT HE WILL CALL BACK IF HE NEEDED ANY FURTHER ASSISTANCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664113 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR