BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972321 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88784
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS IN THE MORNINGS AND THAT THE INSULIN PUMP ALSO ALARMED NO DELIVERY. THE BLOOD GLUCOSE READINGS VARIED FROM 200 TO 300 MG/DL BUT REACHED AS HIGH AS 400 MG/DL ON ONE OCCASION. ON THE MORNING OF THE CALL, THE BLOOD GLUCOSE READING WAS 324 MG/DL. THE CUSTOMER'S MOTHER STATED THAT HER DAUGHTER HAD TWO INSERTION SITE ISSUES, POSSIBLY DUE TO THE SITE BECOMING LOOSE WHILE SHE WAS SLEEPING, WHICH IS WHEN THE DEVICE ALARMED NO DELIVERY. THE CALLER STATED THAT THE INFUSION SET CHANGES WERE GOING FINE AND THAT THEY HAD BEEN WORKING CLOSELY WITH THE NURSE FOR ANY ADJUSTMENTS ON THE DEVICE. THE CUSTOMER'S BLOOD GLUCOSE WAS REPORTED TO STAY WITHIN ITS NORMAL RANGE THROUGHOUT THE DAY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447782 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention