BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972306 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88724
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTS THAT THE CUSTOMER WAS HOSPITALIZED TWICE DUE TO DIABETES KETOACIDOSIS. CUSTOMER WAS HOSPITALIZED ON (B)(6) AND AGAIN ON (B)(6). BLOOD WORK INDICATED CUSTOMER WAS DEHYDRATED AND HAD A BLOOD GLUCOSE LEVEL OVER 900 MG/DL. CUSTOMER WAS TREATED WITH IV CENTRAL LINE FOR INSULIN AND DEHYDRATION. HEALTH CARE PROVIDER STATED CUSTOMER HAD A SLIGHT FEVER. CUSTOMER IS DIAGNOSED WITH DOWNSYNDROME AND MOTHER IS THE PRIMARY CARETAKER. MOTHER DECLINED TROUBLE SHOOTING FOR PUMP, BUT STATED THAT CANNULA NEVER WENT INSIDE THE CUSTOMER'S BODY AND DIDN'T REALIZE IT UNTIL THE CUSTOMER WAS HOSPITALIZED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448071 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization