BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103576 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26666
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE OF 460 MG/DL. CUSTOMER HAD TO CALL THE PARAMEDICS. CUSTOMER STATED THAT IF CUSTOMER HAD HIS SENSOR CUSTOMER BLOOD GLUCOSE WOULD NOT HAVE GONE UP. CUSTOMER DID NOT HAVE SUPPLIES. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584337 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention