BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 501098 · Received December 16, 2003

    Report

    Report Number
    2032227-2003-01406
    Event Type
    Injury
    Date Received
    December 16, 2003
    Date of Event
    November 20, 2003
    Report Date
    November 20, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD SUGAR LEVELS. THE CUSTOMER STATED THAT THE MD BELIEVES THE CAUSE OF THE EVENT WAS HBGS AND DEHYDRATION. THE PROGRAMMING WAS ACCURATE AND THE PUMP PASSED THE LEADSCREW TEST. IT WAS INDICATED THAT THE CUSTOMER DID NOT TREAT HBG WITH A MANUAL INJECTION PRIOR TO THE EVENT. IT WAS CONVEYED TO THE CUSTOMER TO FOLLOW THE TWO HBG RULE AND CALL BACK TO DO FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization