BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233733 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49071
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT TUBING AND RESERVOIR. CONNECTION WAS VERIFIED BY TUGGING ON THE CONNECTOR. CUSTOMER WAS ADVISED TO MANUALLY PUSH INSULIN THROUGH TUBING, INSULIN DID EXIT. CUSTOMER WAS ADVISED TO REWIND THE DEVICE, REINSERT RESERVOIR AND RUN MANUAL PRIME, THE DEVICE DID NOT ALARM. CUSTOMER ALSO STATED THAT ONE TIME INSULIN DID SQUIRT OUT WHEN SETUP THE SET. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715703 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR