BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4141655 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33205
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 RECEIVED A FAILED BATTERY TEST ALARM. IT WAS STATED THAT THE BUTTONS ON THE INSULIN PUMP WERE NOT RESPONDING AND THE THAT THE RESERVOIR WAS SHOWING FULL AND NOW IT IS EMPTY. CUSTOMER ALSO RECEIVED A NO DELIVERY ALARM AFTER BOLUS DELIVERY. BLOOD GLUCOSE VALUE IS 256 MG/DL; UNABLE TO TREAT, NEEDS SET CHANGE. IT WAS STATED THAT THE ALARM IS NOT CLEARED, THE FAILED BATTERY TEST ALARM WILL RECUR WITH EACH NEW BATTERY INSERTED. CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED AND BATTERY COMPARTMENT AND SPRING ARE NOT DAMAGED OR CORRODED. IT WAS ADVISED TO CLEAN THE BATTERY CAP AND REINSERT THE BATTERY; CUSTOMER DID NOT RECEIVE A FAILED BATTERY TEST. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET AND RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621264 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG03LD7

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR