BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240460 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49716
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE HAD BEEN HIGH, FOLLOWING SET CHANGES WITH THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE HAD BEEN AS HIGH AS CLOSE TO 500 MG/DL AND SYMPTOMS INCLUDED FREQUENT URINATION AND BAD BEHAVIOR. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR BUBBLES WERE FOUND. THE TUBING WAS A BIT DARKER IN SOME SPOTS. INSULIN DID EXIT THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. THE SETTINGS WERE CORRECT. LOW RESERVOIR AND LOW BATTERY ALERTS APPEARED IN THE HISTORY. THE BOLUS HISTORY WAS CORRECT. THE HIGH PRESSURE TEST AND SELF-TEST WERE PERFORMED AND PASSED. IT WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722222 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR