BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAL PRDGM INS CL EN US LN

    MDR report key: 1002505 · Received February 26, 2008

    Report

    Report Number
    2032227-2008-00394
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED A BLOOD GLUCOSE READING OF 254 MG/DL. THE CUSTOMER STATED SHE GAVE SEVERAL BOLUSES, BUT HER BLOOD GLUCOSE LEVELS REMAINED HIGH. THE CUSTOMER WAS THEN TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST.

    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 YR Hospitalization