BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4241224 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50078
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP HAS BEEN ALARMING NO DELIVERY. THE FIRST TIME IT HAPPENED, CUSTOMER CHANGED HER INFUSION SET AND BATTERY AND EVERYTHING WAS FINE. YESTERDAY, THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS AND CUSTOMER HAD TO CHANGE HER INFUSION SET AND BATTERY AGAIN. THIS MORNING, THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS AGAIN AND THE BATTERY WAS DEPLETED. CUSTOMER'S BLOOD GLUCOSE WAS 159 MG/DL. IN TROUBLESHOOTING, INSULIN EXITED DURING THE FIXED PRIME. THE CANNULA WAS NOT BENT. CUSTOMER RAN AN ADDITIONAL FIXED PRIME TO MAKE DETERMINE IF THERE IS AN OCCLUSION. INSULIN EXITED THE TUBING. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET AND RESERVOIR AND SEND IT BACK FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723843 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG03GE1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR