BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4183525 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40246
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD DANGEROUS AIR BUBBLES IN THE RESERVOIRS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. CUSTOMER STATED THAT THE APPROXIMATE SIZE OF AIR BUBBLES IS CHAMPAGNE-SIZED. CUSTOMER CHANGED THE SET LAST NIGHT AND NOTICED THE SMALL AIR BUBBLES. CUSTOMER TOOK THE RESERVOIR OUT OF THE PUMP AND PUSHED THE AIR BUBBLES OUT. CUSTOMER FOUND THAT THE PISTON WAS NOT TOUCHING THE RESERVOIR. CUSTOMER REMOVED RESERVOIR AND REWOUND AND PRIMED THE PUMP. CUSTOMER STATED THAT THE PUMP WAS NOT REWOUND WITH A RESERVOIR IN PLACE CUSTOMER WAS ADVISED THAT THE INSULIN SHOULD BE STORED AT ROOM TEMPERATURE TO PREVENT GASSING OUT WHEN IT WARMS IN THE PUMP. INSULIN WAS STORED AT ROOM TEMPERATURE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664029 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR