BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243711 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50346
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S MOTHER REQUESTED INFORMATION ABOUT THE SCROLL WRAP URGENT MEDICAL SAFETY NOTICE. THE CUSTOMER'S MOTHER WAS ADVISED ABOUT THE SAFETY NOTICE. THE CUSTOMER'S MOTHER STATED SHE WOULD HAVE THE CUSTOMER CALL TO HEAR THE INFORMATION. THE CUSTOMER'S BLOOD GLUCOSE LEVELS ARE UNKNOWN. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727321 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR