BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3870931 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85710
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    120010
    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.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT INSULIN PUMP ALARMING NO DELIVERY. CUSTOMER STATED THAT AFTER THEIR THIRD INFUSION SET AND RESERVOIR CHANGE, THE DEVICE STOPPED ALARMING. PATIENT'S BLOOD GLUCOSE LEVEL WAS FLUCTUATING BETWEEN 600 MG/DL TO 700 MG/DL AT THE TIME. CUSTOMER VISITED THEIR HEALTHCARE PROVIDER THE FOLLOWING DAY TO TREAT HIGH BLOOD GLUCOSE LEVELS. PATIENT DECLINED TROUBLESHOOTING INSULIN PUMP AND WOULD NOT RETURN THE DEVICE FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347485 530G INSULIN PUMP OYZ LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR