BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UC EA INSULIN CH EN US

    MDR report key: 1020951 · Received March 28, 2008

    Report

    Report Number
    2032227-2008-00571
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 15, 2008
    Report Date
    March 18, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE SELF-TEST. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD GIVEN AN ERROR ALARM THAT HAD ERASED ALL THE SETTINGS WITHOUT HER KNOWLEDGE. THE CUSOTMER STATED THAT THE INSULIN PUMP HAS BEEN OPERATING NORMALLY SINCE THE HOSPITALIZATION AND DECLINED FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UC EA INSULIN CH EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization