BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4233732 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48943
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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

    CUSTOMER REPORTS TO HAVE GONE BACK ON INSULIN THERAPY AFTER HAVE BEEN OFF FOR A WHILE. CUSTOMER STATES SHE RECEIVED A NO DELIVERY ALARM DURING BOLUS DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 129 MG/DL. DURING TROUBLESHOOTING, CUSTOMER WAS NOT ABLE TO REMOVE INFUSION SET WHILE ON THE PHONE. CUSTOMER STATES HER HEALTHCARE PROFESSIONAL GAVE HER THE INFUSION SET SHE IS WEARING, BUT SHE IS NOT SURE IF IT IS A SURE T OR MIO. CUSTOMER WAS ADVISED TO CHANGE ENTIRE INFUSION SET. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715091 INSULIN INFUSION PUMP OYO LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR