BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233114 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48687
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS IN THE HOSPITAL, DUE TO HIGH BLOOD GLUCOSE OF 700 MG/DL, KETONES, AND A URINARY TRACT INFECTION. THE CUSTOMER STATED THE CANNULA CONNECTING TO HER INSULIN PUMP WAS BENT AND NOT FULLY INSERTED INTO HER BODY. THE CUSTOMER WAS OFF OF THE INSULIN PUMP TWO DAYS PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714472 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization UNOMEDICAL INFUSION SET