BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4211789 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-29324
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 26, 2014
    Report Date
    October 28, 2014
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE ADVERSE REACTION AND THE EMERGENCY MEDICAL SERVICE WAS CONTACTED. THE CUSTOMER REPORTED HIS BLOOD GLUCOSE TO BE 40 MG/DL. THE CUSTOMER ALSO REPORTED THAT HIS BATTERY DOES NOT LAST MORE THAN ONE WEEK. THE CUSTOMER WAS ADVISED TO MONITOR HIS INSULIN PUMP AND CALL THE HOTLINE IN A FUTURE TO TROUBLESHOOT IF HE EXPERIENCES ANY ISSUES AGAIN. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691957 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R