BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170401 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37515
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 HAD HIGH BLOOD GLUCOSE LEVELS OF 244 MG/DL. THE CUSTOMER REPORTED TREATING WITH MANUAL INSULIN SYRINGES. THE CUSTOMER REPORTED A CONCERN THAT THE INSULIN PUMP WAS NOT DELIVERING A PROGRAMMED BOLUS CORRECTLY. TROUBLESHOOTING WAS DONE. MULTIPLE THRESHOLD SUSPEND ALARMS WERE FOUND IN THE ALARM HISTORY OF THE INSULIN PUMP. VARIOUS PROGRAMMED BOLUSES ON THE INSULIN PUMP WERE ALSO VERIFIED IN THE HISTORY OF THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN OF THE INSULIN PUMP. THE CUSTOMER WAS ALSO ADVISED TO TREAT PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651309 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR