BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4160225 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26162
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 168 MG/DL. TROUBLESHOOTING OCCURED AND IT WAS FOUND THAT THE RESERVOIR WAS OCCLUDED. CUSTOMER ALSO REPORTED AIR BUBBLES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581298 RESERVOIR 3ML FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR