BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4120021 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29441
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION EVENT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED HE HAD CHANGED HIS INSULIN AND A FEW HOURS LATER, HIS BLOOD GLUCOSE WAS 600 MG/DL. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 600 MG/DL. THE CUSTOMER STATED HE WAS HYPERGLYCEMIC AND VOMITING PRIOR TO THE HOSPITALIZATION. HE ALSO STATED HE WAS TREATED WITH AN IV OF INSULIN AT THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE HAD DECLINED TO 260 MG/DL AT THE END OF THE TREATMENT. THE CUSTOMER ALSO REPORTED THE HOSPITALIZATION WAS CAUSED BY HIM USING A DIFFERENT BRAND OF INSULIN. THE CUSTOMER ALSO REPORTED RECEIVING A LOST SENSOR AND WEAK SIGNAL ALERT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596792 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization