BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150066 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34824
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 THAT THE CUSTOMER REQUIRED MEDICAL INTERVENTION DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS AT SCHOOL AND THE SCHOOL CALLED BECAUSE THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE MOTHER PICKED HER SON UP AND TREATED HIM WITH A MANUAL INJECTION OF 5 UNITS OF INSULIN. BY THE END OF THE CALL, THE BLOOD GLUCOSE READING HAD LOWERED TO 423 MG/DL. THE CALLER STATED THAT SHE HAD ORDERED THE WRONG INFUSION SETS. THE CUSTOMER HAD A SMALL AMOUNT OF KETONES. THE MOTHER HAD TO CONTACT THEIR DOCTOR REGARDING THE EVENT, AND THE DOCTOR THOUGHT THE ISSUE WAS REGARDING THE INSULIN PUMP. UPON TROUBLESHOOTING, INSULIN DID EXIT DURING A MANUAL PRIME, NO LEAK WAS NOTED, THE ALARM HISTORY WAS CLEAR, AND THE BOLUS HISTORY WAS ACCURATE. IT WAS FOUND THAT THE INFUSION SET HAD A BENT CANNULA AND THAT THE CUSTOMER HAD THE WRONG FILL CANNULA SETTING. ADVISED A COMPLETE INFUSION SET, RESERVOIR AND INSULIN CHANGE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626944 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention