BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161942 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36118
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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 HAD HIGH BLOOD GLUCOSE LEVELS SINCE LAST NIGHT AND CANNOT GET IT DOWN. CUSTOMER ASSUMED THAT IT WAS BECAUSE HIS SET IS ON SOME SCAR TISSUE AND RIGHT NOW IT IS RECEIVING A NO DELIVERY ALARM. CUSTOMER HAS HAD TWO SETS THAT WAS NOT GIVING HIM ANY INSULIN AT ALL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 527 MG/DL. CUSTOMER GAVE A BOLUS BUT DOES NOT KNOW IF IT WORKED. CUSTOMER WAS ADVISED TO CLEAR THE ALARM WITH THE ESC AND ACT BUTTONS. CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT THE TUBING AND RESERVOIR. CUSTOMER VERIFIED THE CONNECTION WAS SECURE AND VERIFIED THAT THE INSULIN EXITED THE TUBING. CUSTOMER RAN A MANUAL PRIME AND THE PUMP DID NOT ALARM NO DELIVERY. CUSTOMER WAS ADVISED THAT THE PUMP WAS WORKING AS DESIGNED. CUSTOMER WAS ABLE TO GET INSULIN TO EXIT TUBING AFTER TROUBLESHOOTING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643664 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR