BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4140859 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33193
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 13, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. (B)(4). PLEASE, SEE MEDWATCH REPORT 2032227-2014-33493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVEL OF 25 MG/DL, WHICH WAS TREATED WITH SUGAR. AT THE TIME OF THE ADMISSION THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER ATTEMPTED CHECKING THEIR BLOOD GLUCOSE IN THE MORNING OF THE PHONE CALL, THEY INSERTED A TEST STRIP INTO THE BLOOD GLUCOSE METER, AND THE METER LIT UP. THERE WAS A MESSAGE ON THE SCREEN THAT REMAINED ON THE DISPLAY UNTIL THE BATTERY OF THE DEVICE DIED. THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS RECESSED. THE CUSTOMER STATED THAT THE PERCEIVED REASON OF THE LOW BLOOD GLUCOSE WAS TAKING TOO MUCH INSULIN AND NOT EATING ENOUGH. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD GONE INTO THRESHOLD SUSPENSE BECAUSE THE SENSOR GLUCOSE READING WAS 50 MG/DL BUT THE CUSTOMER'S BLOOD GLUCOSE WAS 90 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620333 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization