BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2210290 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82128
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER CALLED REQUESTING ASSISTANCE ON REMOVING THE PLUNGER OUT OF THE RESERVOIR. ADVISED THE DIABETES CLINICAL MANAGER OF USING THE PROPER TECHNIQUE. THE CUSTOMER STATED THAT AFTER LOOSENING THE PLUNGER ROD NOTICED INSULIN LEAKING THROUGH PAST O RINGS. NO FURTHER INFO WAS PROVIDED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR