BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4073262 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18343
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM. SHE STATED SHE CHANGED HER INFUSION SET EARLIER TODAY, HAD A MEAL, AND THEN HER DEVICE ALARMED NO DELIVERY. SHE DID ANOTHER INFUSION SET CHANGE, BUT HER BLOOD GLUCOSE WAS STILL HIGH. CUSTOMER DID ONE MORE INFUSION SET CHANGE ABOUT AN HOUR AGO. CUSTOMER'S BLOOD GLUCOSE IS 475 MG/DL. IN TROUBLESHOOTING, INSULIN EXITED THE TUBING DURING A FIXED PRIME. WHEN CUSTOMER REMOVED THE CURRENT INFUSION SET, THE CANNULA WAS BENT. CUSTOMER WAS ADVISED OF POSSIBLE SITE AND INFUSION SET ISSUES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553877 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention