BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3885179 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86000
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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

    CUSTOMER INITIALLY REPORTED THAT SHE WAS AT THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL AND HAVING PROBLEMS WITH BENT CANNULA. HER BLOOD GLUCOSE LEVEL AT TIME OF ADMISSION WAS 590 MG/DL. TROUBLE SHOOTING FOR HIGH BLOOD GLUCOSE LEVELS WAS PERFORMED. DURING TROUBLE SHOOTING CUSTOMER STATED THAT EVENTS THAT LEAD TO THE EMERGENCY ROOM VISIT WAS A BENT CANNULA AND CUSTOMER WAS ALSO IN A CAR ACCIDENT WERE SHE WAS THE DRIVER. CUSTOMER STATED THAT SHE HAD ADMINISTERED 20 UNITS OF INSULIN AND HER BLOOD GLUCOSE LEVEL STILL WENT UP TO 590 MG/DL. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361010 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization