BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183164 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40081
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD CHANGED HER INFUSION SET THIS MORNING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 508 MG/DL. CUSTOMER STATED THAT WHEN SHE DID THE CHANGE, THE DROPS HAPPENED ALMOST IMMEDIATELY. CUSTOMER TREATED WITH AN INJECTION. CUSTOMER WAS CONFUSED AND THIRSTY. CUSTOMER DID NOT CONTACT HER HEALTH CARE PROFESSIONAL FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT SHE HAD A BACK-UP PLAN. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN DID EXIT THE TUBING. PUMP SETTINGS AND HISTORY WERE CHECKED AND FOUND TO BE CORRECT. CUSTOMER PERFORMED THE HIGH PRESSURE TEST AND THE TEST PASSED. CUSTOMER WAS ADVISED TO MONITOR HER BLOOD GLUCOSE AND CALL A DOCTOR IF THE BLOOD GLUCOSE LEVELS CONTINUE TO RISE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660322 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR