BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3942955 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87706
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    CUSTOMER CALLED REPORTING CONSTANT NO DELIVERY ALARMS ON HIS INSULIN PUMP. HIS BLOOD GLUCOSE LEVEL IS 150 MG/DL. DURING TROUBLE SHOOTING, WHEN CUSTOMER RAN A FIVE UNIT FIXED PRIME, INSULIN DID NOT EXIT THE TUBING AND THE DEVICE ALARMED NO DELIVERY. INSULIN EXITED THE TUBING WHEN IT WAS MANUALLY PUSHED. CUSTOMER REWOUND THE DEVICE AND TRIED RUNNING A MANUAL PRIME, BUT IT ALARMED NO DELIVERY. CUSTOMER DOES NOT HAVE ANOTHER INFUSION SET FOR TROUBLE SHOOTING. HE WAS ADVISED THAT THE ALARM MAY HAVE BEEN CAUSED BY A SITE OR INFUSION SET ISSUE. HE WAS ADVISED TO REPLACE THE INFUSION SET AND RESERVOIR AND MONITOR THE DEVICE. CUSTOMER STATED THE RESERVOIR COULD BE A YEAR OR TWO OLD, SINCE HE REUSES THEM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419021 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR