BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972370 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88802
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE CUSTOMER IS HAVING PROBLEMS WITH THE INSULIN PUMP. CUSTOMER'S MOTHER STATED SHE CHANGED THE INFUSION SET AND FORGOT TO FILL TUBING AND CANNULA. TWO DAYS LATER SHE CHANGED THE SET AGAIN AND CUSTOMER HAD HIGH BLOOD GLUCOSE. CUSTOMER'S MOTHER DID SEE DROPS COMING OUT AND DID NOT CHECK IF THE SET WAS KINKED. CUSTOMER'S MOTHER WAS ADVISED TO DO A CHANGE SET AND IF ISSUE PERSISTED TO REACH THE HELPLINE. CUSTOMER ALSO REPORTED SHE HAD INFECTION THE INFUSION SET SITE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448615 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR