BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4081445 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21274
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF OVER 500 MG/DL. THE CUSTOMER REPORTED MULTIPLE NO DELIVERY ALARMS FROM THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. THE CUSTOMER ALSO REPORTED THAT THE CURRENT INFUSION SET MIGHT NOT BE SUITABLE FOR HER SINCE SHE HAS SOME BODY FAT. THE CUSTOMER WAS ADVISED TO USE A DIFFERENT INFUSION SET. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561771 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR