BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5085783 · Received September 17, 2015

    Report

    Report Number
    2032227-2015-45039
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 26, 2015
    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
    OTHER

    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

    A DOCTOR CALLED ON BEHALF OF HIS PATIENT, WANTING TO KNOW HOW TO RAISE THE BASAL RATES. DOCTOR INDICATED THAT THE PATIENT WAS SENT TO EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE OF 744 MG/DL AND DIABETIC KETOACIDOSIS. TROUBLESHOOTING ASSISTED DOCTOR WITH HIS REQUEST. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615531 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other