BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4142237 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33654
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A VISUAL INSPECTION, THE INSULIN PUMP WAS OBSERVED TO HAVE A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS. AN ALARM OCCURRED DUE TO A SOFTWARE ERROR AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD CRACKS NEAR THE BATTERY COMPARTMENT. THE REPORTER DECLINED TO PROVIDE THE BLOOD GLUCOSE READING. ADVISED RETURN OF THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621799 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1