BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3854475 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85283
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    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

    CUSTOMER POSTED A MESSAGE ON SOCIAL MEDIA, SAYING HE WAS HAVING ISSUES WITH CARELINK HOME NOT BEING COMPATIBLE WITH GOOGLE CHROME. HE SAID HE CAN'T VIEW, SAVE, OR SHARE WEEKLY REPORTS WITH DOCTORS. THE CUSTOMER MENTIONED HAVING AN INCIDENT ON EASTER SUNDAY. HE STATED THAT HIS GLUCOSE LEVEL ALWAYS DROPS AROUND 5:30PM. HE WAS COOKING DINNER, HAD A SNACK AND DECIDED TO DO A SENSOR CHANGE. DURING THE PERIOD OF TWO HOURS WAITING FOR INITIALIZATION AND ANOTHER TWO HOURS FOR WETTING, HIS GLUCOSE LEVEL DROPPED TO 38MG/DL. THE CUSTOMER PASSED OUT AND HAD A SEIZURE. THE DAUGHTER GAVE HIM A DRINK AND CALLED THE PARAMEDICS. THEY ARRIVED TO HIS HOUSE AND TREATED WITH GLUCOSE JUICE. THE CUSTOMER DECLINED TO GO TO THE HOSPITAL. THE CALLER STATED THAT HE EXPERIENCED HIGH BLOOD GLUCOSE AND BELIEVED WAS DUE TO A SITE RELATED ISSUE. THE INFUSION SET WAS CHANGED AND HIS GLUCOSE LEVEL WENT DOWN. THE CUSTOMER MENTIONED HAVING HARD TIME TO CONTROL HIS BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332601 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention