BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6125464 · Received November 23, 2016

    Report

    Report Number
    2032227-2016-44167
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 31, 2016
    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
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS 420 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY WERE THROWING UP. THE CUSTOMER STATED THAT THEY WERE GIVEN INSULIN DRIP TO TREAT THE BLOOD GLUCOSE. THE CUSTOMER STATED THAT THEY WERE WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE CUSTOMER ALSO REPORTED THAT THEY HAD BENT CANNULA WHEN THEY GOT TO THE HOSPITAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777106 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization