BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3951384 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88090
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL THE CUSTOMER STATED THAT THEY HAD HIGH BLOOD GLUCOSE AND WERE NOT ABLE TO BRING IT DOWN. THEIR INSULIN PUMP ALARMED NO DELIVERY AT SATURDAY NIGHT. THE CUSTOMER WAS UNABLE TO WORK THE DEVICE, SO, THEY DISCONNECTED THE INFUSION SET FROM THEIR BODY AND TREATED WITH MANUAL INJECTION. LATER, THE SAME DAY, THEY RECONNECTED THE SAME INFUSION SET, AND THE DEVICE WORKED. ON THE WEEKEND THE BLOOD GLUCOSE WAS OKAY BOTH DAYS. BUT, ON MONDAY, THE CUSTOMER WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE OF 349 MG/DL AND WAS ADMITTED. THE CUSTOMER STATED THAT THEY THINK THE HIGH BLOOD GLUCOSE WAS CONTRIBUTED BY URINARY TRACT INFECTION AND NOT THE INSULIN PUMP. THE OUTCOME OF THE HOSPITALIZATION WAS DIABETIC KETOACIDOSIS, HIGH BLOOD GLUCOSE AND URINARY TRACT INFECTION. THE CUSTOMER COULD NOT REMEMBER IF THEY WERE WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 115 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428497 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization