BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6204098 · Received December 26, 2016

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    Report

    Report Number
    2032227-2016-53358
    Event Type
    Injury
    Date Received
    December 26, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 1, 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
    NY
    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.

    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 521 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 310 MG/DL AT THE TIME OF CALL. THE CUSTOMER STATED THAT THEY WERE THROWING UP AND NAUSEA. THE CUSTOMER STATED THAT THEY WERE WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ALARMING NO DELIVERY ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER WAS ADVISED TO TROUBLESHOOT FOR THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853864 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization