BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3833532 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85010
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 10, 2014
    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 STATES THAT HER BLOOD GLUCOSE WAS EXTREMELY HIGH. SHE CAN ONLY REMEMBER WAKING UP IN THE HOSPITAL, 1099 MG/DL. SHE COULD NOT REMEMBER ANY ISSUES THAT OCCURRED WITH THE INSULIN PUMP. SHE ONLY COULD STATE THAT SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HER HOSPITALIZATION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310119 530G INSULIN PUMP OZO OZO MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization