BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3970024 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88389
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THAT THE CUSTOMER REQUIRED MEDICAL INTERVENTION BY PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS IN THE 30 MG/DL RANGE. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED DUE TO THE CUSTOMER HAVING FORGOTTEN TO TURN THE SENSOR ON. SHE HAD THE SENSOR INSERTED IN THE ARM AREA. THE CUSTOMER REPORTED THAT SHE DID NOT FEEL AS THOUGH THE INSULIN PUMP WAS MALFUNCTIONING, THAT IT WAS WORKING PRETTY WELL, AND SHE DECLINED TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446623 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention