BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4242750 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50223
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THERE WAS A EMERGENCY ROOM VISIT FOR HIGH BLOOD GLUCOSE. BLOOD GLUCOSE AT THE TIME OF EMERGENCY ROOM VISIT WAS 480 MG/DL. THE DESCRIPTION OF THE CUSTOMER'S COMPLAINT WAS DIABETIC KETOACIDOSIS AND THE PUMP WAS NOT DELIVERING INSULIN. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725508 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR