BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4251852 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-53086
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 THE CUSTOMER WAS HOSPITALIZED FOR HAVING HIGH BLOOD GLUCOSE. DATE OF ADMISSION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 514 MG/DL. THE CUSTOMER STATED THEY HAD BEEN OFF OF THE INSULIN PUMP FOR A FEW DAYS PRIOR TO BEING ADMITTED INTO THE EMERGENCY ROOM. THE CUSTOMER ALSO REPORTED A KEYPAD ANOMALY ON THEIR INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 468 MG/DL AT THE TIME OF THE CALL. CUSTOMER HAD TREATED THEIR HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. IT WAS FOUND THE CUSTOMER'S NUMBERS WERE RAMPING UP ON THEIR INSULIN PUMP. THE CUSTOMER DECLINED TO REPLACE THEIR INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737121 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization