BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3852414 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85465
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    March 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR ONE NIGHT WITH HIGH BLOOD GLUCOSE OVER 400MG/DL. THE CALLER MENTIONED THAT THE CUSTOMER HAD BENT CANNULAS. THE FATHER STATED THAT THE CUSTOMER DID NOT USE THE INSULIN PUMP FOR A MONTH. IT WAS MENTIONED THAT THE DOCTOR CONFIRMED THAT THE INFUSION SET WAS AN ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328770 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization