BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAP PRDGM INS PL EN US RC

    MDR report key: 1252826 · Received December 4, 2008

    Report

    Report Number
    2032227-2008-02035
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 607 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME AND HIGH PRESSURE TESTS PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAP PRDGM INS PL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization