BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4240455 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49711
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS PERFORMING AN INFUSION SET CHANGE AND UPON "WITING" THE PLUNGER OF HER RESERVOIR, A LARGE BUBBLE BEGAN TO FORM AT THE TOP. THE CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL. THE CUSTOMER WAS UNABLE TO REMOVE THE PLUNGER ROD. SHE WAS ADVISED TO TWIST THE PLUNGER COUNTER-CLOCKWISE SLOWLY, WHILST CAREFULLY HOLDING THE RESERVOIR IN PLACE. UPON DOING SO, SHE STATED SHE PULLED THE BOTTOM FROM THE RESERVOIR AND LOST ALL OF HER INSULIN. THE CUSTOMER WAS ADVISED TO USE ANOTHER RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722695 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG0892K

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR