BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4203393 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43650
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 CUSTOMER HAD CHANGED THE INSULIN PUMP AND THE SENSOR AND HIS BLOOD GLUCOSE WAS IN THE 500 MG/DL RANGE. CUSTOMER WAS GIVEN A FULL DOSAGE AND NOW BLOOD GLUCOSE WAS AT 548 MG/DL. CUSTOMER DID NOT REMOVE NEEDLE GUARD AND THE QUICK SET STUCK TO THE CUSTOMER BUT DID NOT GO ALL THE WAY IN AND HE WAS NOT GETTING INSULIN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S MOTHER WAS ADVISED TO DISCONNECT THE DEVICE. THE DRIVE SUPPORT CAP APPEARED NORMAL. AIR BUBBLES ABOUT A QUARTER OF AN INCH LONG. SETTINGS ON THE DEVICE WERE CORRECT. ALARM HISTORY ONLY SHOWED A NO DELIVERY ALARM. HIGH PRESSURE TEST WAS PERFORMED AND DEVICE PASSED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683266 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR