BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142069 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33361
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 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 FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE LEVEL OF 46 MG/DL THE NIGHT BEFORE THE CALL AND OVER 500MG/DL SHORTLY BEFORE THE CALL. CALLER REPORTED THAT THE LOW BLOOD GLUCOSE LEVEL WAS TREATED WITH GLUCOSE TABS AND THE HIGH GLUCOSE LEVEL WAS TREATED WITH A MANUAL INJECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621708 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR