BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 2PK 3ML

    MDR report key: 3120956 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93787
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER HAS A LEAKING RESERVOIR. CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE READING IS 362 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER STATES THE INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT. THE LEAK IS PAST THE SECOND O-RING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222396 RESERVOIR 2PK 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332AT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR