BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3946022 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-88047
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS NOT ALARMING THRESHOLD SUSPEND AFTER THEY HAD LOW BLOOD GLUCOSE LEVELS. CUSTOMER STATED SHE HAD NOT TREATED FOR LOW BLOOD GLUCOSE LEVELS PRIOR TO THE CALL. ADVISED CUSTOMER TO ALWAYS TREAT WHEN THEY ARE HAVING HIGH OR LOW BLOOD GLUCOSE LEVELS PER BACK UP PLAN. DURING TROUBLESHOOTING, CUSTOMER WAS INFORMED OF THE PHYSIOLOGICAL LAG TIME. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 110 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426021 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR