BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511NAL PRDGM EA INS CL EN

    MDR report key: 1040216 · Received May 8, 2008

    Report

    Report Number
    2032227-2008-00790
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 26, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER'S HUSBAND STATED THAT THE CUSTOMER WAS TREATED IN THE EMERGENCY ROOM FOR BLOOD GLUCOSE LEVELS OVER 500 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE THE TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST. IT WAS ALSO STATED THAT THE CUSTOMER WAS TAKING ANTIBIOTICS FOR AN INFECTION. THE CUSTOMER ALSO WEARS THE INFUSION SETS FOR MORE THAN THREE DAYS ON OCCASION. ADVISED THAT A TUBING CLAMP WOULD BE SENT AND INSTRUCTED TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST. EXPLAINED THAT INFUSION SETS SHOULD BE WORN FOR TWO TO THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511NAL PRDGM EA INS CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention