BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1821581 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82462
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT, OCCLUSION AND EXCESSIVE NO DELIVERY TESTS. HOWEVER, MOISTURE DAMAGE WAS NOTED ON THE MOTOR ASSEMBLY AND LIQUID CRYSTAL DISPLAY BOARD DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER CHANGED THE INFUSION SET FOUR TIMES AND NOTICED THAT INSULIN HAD LEAKED INTO THE RESERVOIR COMPARTMENT. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR