BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183054 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40004
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 19, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    CUSTOMER REPORTED A HOSPITALIZATION EVENT FOR HIGH BLOOD GLUCOSE ON (B)(6) 2014. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF ADMISSION. HE STATED HE WAS UNSURE WHAT HAD HAPPENED BUT HIS BLOOD GLUCOSE WAS HIGH AND HE WAS THROWING UP. HE ALSO REPORTED THAT HE WAS NOT ABLE TO MOVE. IT WAS FOUND THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE HOSPITAL TREATED THE CUSTOMER WITH AN INSULIN DRIP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661939 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization