BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3801031 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84381
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE INSULIN PUMP WAS SHUTTING OFF AND NOT DELIVERING INSULIN. THE INCIDENT HAPPENED THREE MONTHS AGO. THE UNDER-DELIVERY OF INSULIN CAUSED A HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 500 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP'S SCREEN WAS BLANK AND NO INSULIN DELIVERY. THE INSULIN PUMP HAS COSMETIC DAMAGE AT THE BATTERY COMPARTMENT. HOSPITAL TREATED AND RELEASED THE CUSTOMER. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277619 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization