BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3884146 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85942
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    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 HAD LOW BLOOD GLUCOSE LEVELS. CUSTOMER HAD RECEIVED LOW SENSOR GLUCOSE, BUT BLOOD GLUCOSE WAS NORMAL. CUSTOMER TURNED OFF SENSOR, ALSO SHE HAD NOT BEEN EATING WELL AND IT MIGHT BE ANOTHER REASON FOR THE LOW BLOOD GLUCOSE. IT WAS STATED THEY FOUND CUSTOMER UNRESPONSIVE AND CALLED PARAMEDICS, BUT WAS NOT HOSPITALIZED. PARAMEDICS ARRIVED AND CUSTOMER'S BLOOD GLUCOSE WAS 15MG/DL, THEY TREATED CUSTOMER AND BLOOD GLUCOSE READING WAS 94MG/DL. CUSTOMER IS PREGNANT, AND STATED SHE HAD THE SAME LOW BLOOD GLUCOSE IN THE PASS. CUSTOMER STATED IT WAS NOT THE INSULIN PUMP AND SHE WILL CONTINUE MONITORING HER BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 15MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361234 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention