BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233754 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49208
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 750 MG/DL. THE CUSTOMER STATED THAT SHE WAS ON CHEMOTHERAPY AND STEROIDS THAT CAUSED HER BLOOD GLUCOSE LEVELS TO RISE. SHE WAS TREATED AND RELEASED. SHE NOTED THAT SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF ADMITTANCE. SHE NOTED THAT FOR SOME REASON SHE COULD NOT KEEP HER BLOOD GLUCOSE LEVELS UNDER CONTROL THAT DAY AND WOUND UP IN THE HOSPITAL, BUT SHE ADVISED THAT HER DOCTOR HAD SINCE SHOWN HER HOW TO CHANGE HER BASAL RATES TO PREVENT HIGH BLOOD GLUCOSE. ADVISED THE CUSTOMER TO CALL WHEN ANY ISSUES OCCURRED TO TROUBLESHOOT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715098 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization