BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3833530 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85036
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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

    PHYSICIAN'S ASSISTANT REPORTED CUSTOMER HAD HIGH AND LOW BLOOD GLUCOSE LEVELS THAT REQUIRED MEDICAL ATTENTION. PHYSICIAN'S ASSISTANT STATED THAT THE CUSTOMER HAD A BLOOD GLUCOSE READING OF 23 MG/DL ON THE NIGHT OF (B)(6), AND A BLOOD GLUCOSE READING OF OVER 400 MG/DL THE FOLLOWING MORNING. CUSTOMER HAS NOT BEEN TRAINED TO INSERT THE NEW SENSORS AND A REQUEST FOR TRAINING HAS BEEN SENT. THE PARAMEDICS WERE CALLED. THE PHYSICIAN'S ASSISTANT WAS NOT ABLE TO PROVIDE ANY INFORMATION REGARDING THE EMERGENCY CALL AND THE CUSTOMER HAS NOT YET CALLED BACK TO PROVIDE FURTHER DETAILS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310392 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention