BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150056 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34818
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE TIME OF ADMITTANCE WAS UNKNOWN, BUT THE CUSTOMER STATED THAT AT ONE POINT THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE CUSTOMER COMPLAINED OF VOMITING, HEADACHE, INABILITY TO LOWER BLOOD GLUCOSE LEVELS, AND A POSSIBLE INFECTION. SHE WAS TREATED WITH AN INSULIN DRIP. SHE NOTED THAT SHE WAS ALSO BEING TREATED WITH HER BASAL RATES THROUGH THE INSULIN PUMP IN ADDITION TO THE INSULIN DRIP. THE CUSTOMER WAS UNABLE TO PERFORM AN INFUSION SET CHANGE BECAUSE SHE DID NOT HAVE THE SUPPLIES ON HER. SHE PERFORMED A BOLUS AND IT DELIVERED INSULIN FINE. SHE DECLINED FURTHER TROUBLESHOOTING DUE TO NOT WANTING TO INTERFERE WITH THE CURRENT BOLUS DELIVERY. ADVISED THE CUSTOMER TO GATHER SUPPLIES NEEDED FOR FURTHER TESTING ON THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628090 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization