BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170437 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37951
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WAS HOSPITALIZED FOR A LOW BLOOD GLUCOSE LEVEL OF 40 MG/DL. THE PATIENT WAS TREATED WITH FOOD AND JUICE. THE CUSTOMER STATED THAT THE ISSUE WAS CAUSED BY ADJUSTING THE SETTINGS ON THEIR INSULIN PUMP. THE CUSTOMER READJUSTED THE SETTINGS AND DID NOT GET ANYMORE LOW BLOOD GLUCOSE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651375 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization