BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511WWB PRDGM INSULIN BL EN

    MDR report key: 1770202 · Received July 20, 2010

    Report

    Report Number
    2032227-2010-81918
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 18 MG/DL. THE CUSTOMER HAD GONE OUT FOR A WALK THAT DAY, AND HIS BLOOD GLUCOSE LEVELS WERE NORMAL BEFORE HE LEFT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE SELF TEST, BUT IT WAS NOT POSSIBLE TO CONDUCT THE HIGH PRESSURE TEST. THE CUSTOMER ALSO FELT THAT 20 UNITS OF INSULIN WERE MISSING FROM THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511WWB PRDGM INSULIN BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization