BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6114819 · Received November 18, 2016

    Report

    Report Number
    2032227-2016-43098
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY WERE HAVING ISSUES WITH BENT CANNULAS. THE CUSTOMER'S MOTHER REPORTED THAT THEY HAD HIGH BLOOD GLUCOSE OF 420 MG/DL AND 508 MG/DL WITH BENT CANNULAS. THE CUSTOMER'S MOTHER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER'S MOTHER ALSO STATED THAT THEY CHANGED THE INFUSION SET TO RESOLVE THE ISSUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764666 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other