BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221742 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46700
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . 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 THAT THE CUSTOMER HAD TROUBLE WITH HER BLOOD SUGAR GOING HIGH. CUSTOMER TOOK 15 UNITS AN HOUR AND A HALF AGO WITH A NOVOLOG PEN, BUT HER BLOOD GLUCOSE LEVEL WAS STILL GOING UP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 547 MG/DL. CUSTOMER CHECKED HER BLOOD GLUCOSE ON THE FREESTYLE LIGHT AND IT WAS 459 MG/DL. CUSTOMER STATED THAT SHE HAS A BACKUP PLAN AND HAS TREATED FOR HER HIGH BLOOD GLUCOSE LEVELS. CUSTOMER HAS A BENT CANNULA ON (B)(6) 2014 AND 2 SITE OCCLUSIONS ON (B)(6) 2014. CUSTOMER DISCONNECTED AT THE QUICK RELEASE AND FOUND AIR IN THE TUBING. CUSTOMER RAN A MANUAL PRIME AND STATED THAT THE INSULIN DID EXIT THE TUBING. CUSTOMER'S SETTINGS AND BASAL RATES WERE REVIEWED AND FOUND TO BE CORRECT. CUSTOMER PERFORMED THE HIGH PRESSURE TEST AND THE PUMP PASSED. CUSTOMER WAS ADVISED THAT THE PUMP WAS WORKING AS DESIGNED. CUSTOMER STATED THAT THE CANNULA WAS NOT OCCLUDED. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SYSTEM. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702499 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR