BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4820100 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-61822
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    March 1, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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

    THE CUSTOMER REPORTED VIA A FOLLOW UP PHONE CALL THAT SHE HAD BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, DIABETIC KETOACIDOSIS, DEHYDRATION AND THYROID ISSUES. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 170 MG/DL, AND THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF ADMISSION. THE CUSTOMER STATED THAT SHE WAS ADMITTED FOR 2 DAYS. SHE NOTED THAT, BECAUSE SHE WAS SICK, SHE SUSPENDED THE INSULIN PUMP. SHE COMPLAINED OF ACCELERATED HEART RATE. SHE REPORTED THAT FOR MOST OF THE DURATION IN WHICH SHE WAS HOSPITALIZED, HER BLOOD GLUCOSE WAS IN THE 200 MG/DL RANGE, AND SHE WAS BEING TREATED WITH MANUAL INJECTIONS. SHE ADVISED THAT SHE HAD NOT HAD ANY FURTHER ISSUES SINCE THE EVENT AND DECLINED TROUBLESHOOTING FOR THE MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362532 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization