BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193626 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41320
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER DECLINED TO BE TRANSFERRED TO HELP LINE. INBOX MESSAGE STATES THAT CUSTOMER BELIEVES INSULIN DELIVERY OF INSULIN PUMP IS INCORRECT DUE TO HIGH BLOOD GLUCOSE. IT IS REPORTED THAT CUSTOMER'S BLOOD GLUCOSE WAS OVER 500 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER DID NOT GET A "NO DELIVERY" AND UPON REMOVING INFUSION SET IT WAS FOUND THAT CANNULA WAS NOT BENT. IT IS BELIEVED THAT INSULIN WAS BAD. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672018 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention