BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243991 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50373
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 14, 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

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS NOT WORN THE DEVICE SINCE (B)(6) AND SHE DOES NOT KNOW THE DATE OF HOSPITALIZATION. CUSTOMER HAD NOT REMOVED THE REPLACEMENT PUMP FROM THE BOX DUE TO HER HOME BEING UNDER CONSTRUCTION. CUSTOMER WAS ADMITTED AROUND (B)(6)AROUND 1-2 AM. THE CAUSE OF THE CUSTOMER'S LOW BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ADMITTED DUE TO HAVING A SEIZURE IN THE NIGHT. CUSTOMER STATED THAT SHE HAS STOPPED WEARING THE DEVICE. CUSTOMER'S HUSBAND GAVE HER GLUCAGON AND INSISTED THAT SHE GO TO THE HOSPITAL. CUSTOMER STATED THAT IT STOPS WORKING WHEN SHE ROLLS OVER AT NIGHT TIME. CUSTOMER ALSO HAD ISSUES WITH INSERTING THE SENSOR. SHE STATED THAT THE ONE SENSOR WAS MUCH EASIER TO INSERT FOR HER. CUSTOMER IS NO LONGER USING THE PUMP AT THE RECOMMENDATION OF HER HEALTH CARE PROFESSIONAL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726232 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization