BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4061179 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16775
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    CUSTOMER REPORTED THROUGH THE OUTREACH PROGRAM THAT HE HAD A HIGH AND LOW BLOOD GLUCOSE EVENT WHEN USING THE CONTINUOUS GLUCOSE MONITORING SYSTEM. HE STATED HE WOULD HAVE ISSUES WITH INACCURATE SENSOR READINGS. CUSTOMER WOULD TREAT BASED OFF THE INACCURATE SENSOR READINGS, CAUSING HIM TO GO HIGH OR LOW. WHEN CUSTOMER WAS HIGH, HIS BLOOD GLUCOSE WAS 528 MG/DL. WHEN HE WAS LOW, HIS BLOOD GLUCOSE WAS 41 MG/DL. CUSTOMER STATED HE BELIEVES THE PROBLEM MAY BE THAT HE DOES NOT HAVE ANY GOOD ABDOMEN INSERTION SITES. CUSTOMER HAS STOPPED USING THE SENSORS ABOUT TWO TO THREE MONTHS AGO. CUSTOMER CURRENT BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540706 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention