BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4133770 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32007
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 DUE TO LOW BLOOD GLUCOSE LEVELS. THE AMBULANCE WAS CALLED AND THE PARAMEDIC TREATED THE CUSTOMER WITH GLUCOSE, HE WAS THEN TRANSPORTED TO THE HOSPITAL. BLOOD GLUCOSE LEVELS AT THE TIME OF THE HOSPITALIZATION 41MG/DL. CUSTOMER REPORTED THAT HE WAS OVERLY ACTIVE THE PREVIOUS DAY AND HE WAS SO TIRED THAT HE DID NOT WANT TO GET UP IN THE MIDDLE OF THE NIGHT TO CALIBRATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611148 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization