BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4260093 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-54501
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    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 THE CUSTOMER RECEIVED A COMMUNICATION ERROR ALARM. THE CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. TROUBLESHOOTING FOUND THE INSULIN PUMP PASSED THE SELFTEST. THE CUSTOMER ALSO REPORTED RECEIVING SEVERAL OTHER ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS 70 MG/DL. THE CUSTOMER WAS ADVISED TO MONITOR THEIR INSULIN PUMP AND BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745916 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508RUB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR