BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3982014 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89992
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 30, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY THE DAY PRIOR, AND THE BLOOD GLUCOSE READING WAS 500 MG/DL; HE CHANGED THE INFUSION SET, THEN BROUGHT THE BLOOD GLUCOSE READING DOWN TO 360 MG/DL. THE CUSTOMER DID NOT KNOW THE HOSPITAL CONTACT INFORMATION NOR THE DOCTOR'S NAME. HE WAS TREATED AND RELEASED WITH A BLOOD GLUCOSE READING OF 180 MG/DL, AND THE MOST RECENT READING WAS 79 MG/DL. THE CUSTOMER STATED THAT HE HAD REPORTED THE INCIDENT TO HIS DOCTOR. NO FURTHER ASSISTANCE WAS NECESSARY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458533 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization