BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945584 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87855
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 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.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL THE CUSTOMER STATED THAT A WEEK PRIOR THE INSULIN PUMP ALARMED CALIBRATION ERROR AND MULTIPLE NO DELIVERIES. HE REPORTED LOW BLOOD GLUCOSE DUE TO TOO MUCH INSULIN, WHICH THE CUSTOMER WAS NOT CERTAIN WHY. HE STATED THAT HIS BLOOD GLUCOSE WAS VERY SDONE BECAUSE THE CUSTOMER WAS DRIVING. HE STATED THAT THERE WERE VARIATIONS IN THE SENSOR AND THE BLOOD GLUCOSE; 171 MG/DL WITH ONETOUCH AND 232 MG/DL WITH NEXTLINK. THE CUSTOMER WAS ADVISED THAT THIS IS OFF LABEL USE, AND THAT USING MULTIPLE METERS FOR CALIBRATION CAN CONTRIBUTE TO INACCURATE READINGS. THE CUSTOMER STATED THEY CALIBRATE ONLY TWICE A DAY. WHEN CALIBRATION ERRORS OCCUR HE TURNS OFF THE SENSOR AND/OR CHARGES THE TRANSMITTER WHICH RESOLVES THE ISSUE. CALIBRATION ERROR AND SENSOR END HAPPENED PRIOR TO THE 7TH DAY. HE ALSO NOTED MANY WEAK SIGNAL ALERTS WHEN THE INSULIN PUMP IS UNDER THE PILLOW. HE STATED THAT ON THE DAY OF THE PHONE CALL EVERYTHING WAS FUNCTIONING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424726 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR