BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141189 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32785
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND DUE TO ISSUES WITH THE SENSOR. BLOOD GLUCOSE READING WAS 30 MG/DL. THE CUSTOMER STATED THAT THE SENSOR WASN'T CALIBRATING. THERE WAS ALSO BLEEDING AT THE SITE WHEN THE SENSOR WAS REMOVED. THE CUSTOMER PROGRAMMED THE INSULIN PUMP TO ACTIVATE THRESHOLD SUSPEND AT 70 MG/DL. THE INSULIN PUMP DID NOT GO INTO THRESHOLD SUSPEND AND HER BLOOD GLUCOSE READING DROPPED TO 30 MG/DL. THE CUSTOMER TREATED FOR THE LOW BLOOD GLUCOSE AND WHEN THE BLOOD GLUCOSE READING WENT BACK UP TO 90 MG/DL THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND. TROUBLESHOOTING WAS PERFORMED AND THE CANNULA WAS FOUND TO BE BENT. ADVISED THAT THE ISSUES MAY HAVE BEEN CAUSED BY THE BENT CANNULA. CUSTOMER DECLINED TROUBLESHOOTING FOR THE OTHER REPORTED ISSUES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619658 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR