BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1052827 · Received May 27, 2008

    Report

    Report Number
    2032227-2008-00887
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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 STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED A BLOOD GLUCOSE READING OF 600 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE HIGH PRESSURE TEST WAS PERFORMED USING A HEMOSTAT BECAUSE THE CUSTOMER DID NOT HAVE A TUBING CLAMP. THE INSULIN PUMP DID NOT PASS THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST ONCE SHE HAS THE TUBING CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization