BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4181473 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39584
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 THE CUSTOMER HAD A NO DELIVERY ALARM AND HAD CHANGED INFUSION SETS ABOUT 4-5 TIMES SINCE SUNDAY BUT COULD NOT FIND ANY PROBLEM WITH THE INFUSION SET OR RESERVOIR. CUSTOMER STATED THERE WERE CONSTANT NO DELIVERY ALARMS DURING BOLUS/BASAL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 134 MG/DL. CUSTOMER WAS UNABLE TO TROUBLESHOOT BECAUSE SHE WAS USING AN OLD EXPIRED RESERVOIR. CUSTOMER WILL CALL BACK TO ORDER NEW SUPPLIES AFTER A VISIT TO THE DOCTOR ON 09/29/2014. CUSTOMER DOES NOT WANT TO RETURN THE RESERVOIR FOR ANALYSIS. EMERGENCY SUPPLIES WILL BE SENT UNTIL THE CUSTOMER SEES THE DOCTOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660002 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H7574528

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR