BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3973909 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88851
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN WAS NOT CALIBRATING CORRECTLY AND THE DEVICE ALARMED. CUSTOMER STATES THAT THE DEVICE HAS BEEN UNABLE TO CALIBRATE THEIR BLOOD GLUCOSE LEVELS CORRECTLY AND HAS ALARMED WITH BLOOD GLUCOSE LEVELS OFF BY AS MUCH AS FORTY POINTS. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE AIR BUBBLES IN INFUSION SET TUBING. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. ADVISED CUSTOMER DEVICE IS FUNCTIONING PROPERLY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 30 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450910 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR