BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2791850 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07434
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 INSULIN CONTINUES TO SPILL OUT FROM THE RESERVOIRS. THE CALLER STATED THAT CUSTOMER IS LOW ON INSULIN IN HIS VIAL BECAUSE THIS CONTINUES TO HAPPEN. THE CAREGIVER WANTED TO KNOW IF THE CUSTOMER COULD DRAW INSULIN FROM OLD VIALS. EXPLAIN THE CALLER THAT IT IS NOT RECOMMENDED. ALSO, ADVISED TO CONTACT HIS DOCTOR ABOUT INSULIN AND HAVE THE CUSTOMER CALL IN TO TROUBLESHOOT THE DEVICE. ADVISED TO REVERT TO BACK UP PLAN UNTIL NEW INSULIN VIALS ARRIVE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR