BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3953990 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88104
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PAST EVENT OF HIGH BLOOD GLUCOSE OF OVER 600 MG/DL AND A LEAK IN THE INSULIN PUMP. AT THAT TIME THE CUSTOMER WENT TO THEIR DOCTOR'S OFFICE. THE CUSTOMER STATED THAT 2 OR 3 MONTHS PRIOR TO THE PHONE CALL THEY WERE NOT SURE IF THERE WAS A LEAK IN THE INSULIN PUMP, BECAUSE THE DEVICE WAS REALLY STICKY AND FELT WET. UPON CHECKING THEY REALIZED THAT A LEAK OCCURRED IN THE RESERVOIR COMPARTMENT BUT THERE WAS NO VISIBLE MOISTURE IN THE INSULIN PUMP. THE DEVICE OPERATED NORMALLY AFTER THE INCIDENT; NO ALARMS HAD OCCURRED, THE BUTTONS ON THE KEYPAD WERE NOT STICKING. THE DEVICE PASSED THE SELF TEST. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 325 MG/DL; THEY JUST ATE AND BLOUSED. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A CRACK ON THE FRONT, IN THE RESERVOIR COMPARTMENT, FROM WEAR AND TEAR. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431372 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR