BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241740 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50664
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 40 MG/DL WHEN THE CUSTOMER'S SISTER CONTACTED EMERGENCY MEDICAL SERVICES. THE CUSTOMER'S SISTER'S NEIGHBOR, WHO IS A REGISTER NURSE, ASSISTED WITH THE ADVERSE EVENT. THE CUSTOMER STATED THAT EMERGENCY MEDICAL SERVICES TREATED HIM AT THE SCENE, BUT HE WAS NOT HOSPITALIZED FOR THE ISSUE. HE PERCEIVED THAT THE CAUSE OF LOW BLOOD GLUCOSE WAS EXTREME PHYSICAL ACTIVITY. NO SIGNIFICANT EVENTS LEADING UP TO THE EVENT WERE NOTED. HE ADVISED THAT HE WAS NO LONGER USING THE INSULIN PUMP THERAPY SYSTEM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723291 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention