BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2081690 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-80947
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LEAKING RESERVOIRS. THE CUSTOMER STATED THAT THE LEAK WAS NEAR THE TRANSFER GUARD OF THE RESERVOIR, BUT HE WAS UNSURE EXACTLY WHERE THE LEAK WAS LOCATED. THE CUSTOMER ALSO STATED THAT HE HAD ALREADY CHANGED HIS INFUSION SET AND RESERVOIR TWICE AND THIS HAD OCCURRED BOTH TIMES. THE CUSTOMER THEN STATED THAT HE WAS NOT DEGASSING THE INSULIN VIALS. IT WAS EXPLAINED TO THE CUSTOMER HOW TO PROPERLY DEGAS INSULIN VIALS AND HOW TO SECURELY SNAP THE TRANSFER GUARD ON TOP TO AVOID LEAKAGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7781716

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR