BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221461 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46639
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 IS REPORTED THAT A CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 456 MG/DL. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS NOT DELIVERED INSULIN FROM THEIR PUMP. THE CUSTOMER ALLOWED HER BOYFRIEND TO SPEAK ON HER BEHALF. THE CUSTOMER DID NOT CONTACT THEIR HEALTH CARE PROVIDER, BUT WAS TREATED WITH 7 UNITS OF INSULIN. THE CUSTOMER DID NOT WANT TO TROUBLE SHOOT ANY FURTHER AFTER A FIXED 5 UNIT PRIME. THE CUSTOMER WAS ADVISED TO LOOK FOR ONLINE SOURCES FOR ANY ADDITIONAL HELP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701388 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR