BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132478 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30554
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    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).

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTS THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. IT IS REPORTED THAT CUSTOMER'S BLOOD GLUCOSE WAS 478 MG/DL, AND 481 MG/DL WHICH WERE TREATED WITH MANUAL INJECTION. BLOOD GLUCOSE WAS LOWERED TO 277 MG/DL. CUSTOMER'S BLOOD GLUCOSE AT TIME OF CALL WAS 438 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED ON INSULIN PUMP AND CUSTOMER WAS ADVISED TO CHANGE INFUSION SET AND RESERVOIR AND FOLLOW HEALTH CARE PROFESSIONAL INSTRUCTIONS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611411 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention