BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4111107 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-23037
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 22, 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 VIA E-MAIL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AND ALARMS AND SENSOR ALARMS ISSUES. THE CALLER STATED THAT SHE CHANGED THE SENSOR FRIDAY MORNING AND IN THE MIDDLE OF THE NIGHT IT WAS GOING CRAZY AND STATED TO SUSPEND. THE CUSTOMER CHECKED HER GLUCOSE LEVEL AND IT WAS COMPLETELY OFF. THEN SHE TURNED OFF THE SENSOR THE NEXT DAY. THE CUSTOMER STATED THAT SHE CALIBRATES BEFORE MEALS AND AT BED TIME. SHE HAS BEEN FRUSTRATED AND STATED THAT THE DIABETES EDUCATOR DOES NOT KNOW WHY ON THE REPORTS THERE MIGHT BE A SPIKE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591715 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR