BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110534 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27384
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT HER SON WOKE UP WITH HIGH BLOOD GLUCOSE AND CURRENTLY IN THE HOSPITAL. THE BLOOD GLUCOSE READING WAS 600 MG/DL. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 146 MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. CUSTOMER HAD A FLU SHOT 3 DAYS BEFORE THE HOSPITALIZATION AND WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. TROUBLESHOOTING WAS DONE. ADVISED CUSTOMER THE 2 HIGH BLOOD GLUCOSE. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592025 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization