BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3841656 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85237
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THE CUSTOMER'S MOM CALLED IN TO REPORT THAT HER CHILD WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. SHE STATES THAT HER SON WAS PLAYING BASEBALL AND BEGAN TO VOMIT. SHE STATES THAT HE HAD VOMITED FIVE TIMES SINCE THE BASEBALL INCIDENT AND THAT IS WHAT ALERTED HER TO TAKE HIM TO THE EMERGENCY ROOM. THE DOCTOR EXPLAINED THAT HER SON'S KETONES WERE EXTREMELY HIGH. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 438 MG/DL. THE CUSTOMER'S MOM SAID THAT HER SON WAS FINE THE NIGHT BEFORE AND HE WOKE UP FEELING ILL THE NEXT MORNING. THE CUSTOMER'S MOM NOTED THAT THERE WERE EXCESSIVE NO DELIVERY ALARMS AND A BENT CANULA. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318074 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization