BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAL PRDGM INS CL EN US LN

    MDR report key: 1941858 · Received December 22, 2010

    Report

    Report Number
    2032227-2010-83499
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR OPEN HEART SURGERY, AND WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 490 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS MAY BE HIGH DUE TO THE STRESS OF THE SURGERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization