BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPANSE LABORATORY/MICROBIOLOGY

    MDR report key: 20706009 · Received November 18, 2024

    Report

    Report Number
    3009404844-2024-00001
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 18, 2024
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    JQP
    UDI-DI
    00863529000155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT EVENT WAS NOT CAUSED BY A SOFTWARE MALFUNCTION WITHIN MEDICAL INFORMATION TECHNOLOGY, INC'S CLASS I EXPANSE LABORATORY/MICROBIOLOGY PRODUCT. UPON BEING NOTIFIED OF THE ADVERSE EVENT ON OCTOBER 23, 2024, MEDICAL INFORMATION TECHNOLOGY, INC,'S CLIENT SUPPORT TEAM REVIEWED THE CUSTOMER'S CONFIGURATION AND CONFIRMED A REPORT CONTAINING THE INITIAL URINE CULTURE RESULTS FROM (B)(6) 2024 WAS NOT SENT TO THE ORDERING PROVIDER. THE CUSTOMER HAD CONFIGURED THEIR SYSTEM TO EXCLUDE TELECOMMUNICATIONS TO THE LOCATION WHERE THE PATIENT'S SPECIMEN WAS RECEIVED FROM. THIS PREVENTED THE REPORT FROM FAXING. FURTHER INVESTIGATION BY MEDICAL INFORMATION TECHNOLOGY, INC. DETERMINED THAT THE CUSTOMER, ON THEIR OWN, HAD CORRECTED THEIR CONFIGURATION ON (B)(6) 2024 TO INCLUDE THE LOCATION WHERE THE PATIENT'S SPECIMEN WAS RECEIVED FROM. THIS WAS TWO DAYS BEFORE THE ADVERSE EVENT WAS REPORTED TO MEDICAL INFORMATION TECHNOLOGY, INC. ON OCTOBER, 23 2024.

    Description of Event or Problem · 0

    ON OCTOBER 23, 2024 A CUSTOMER REPORTED AN ADVERSE EVENT WHERE A PATIENT'S REPORT WAS NOT FAXED FROM THE LABORATORY TO THE ORDERING PROVIDER AFTER MICROBIOLOGY CULTURE RESULTS WERE VERIFIED. CONCERNS WERE RAISED ABOUT THE PATIENT'S ADMISSION TO THE HOSPITAL DUE TO SEPSIS. THE CUSTOMER ASSERTED THAT THE ADMISSION COULD HAVE BEEN AVOIDED IF THE PROVIDER HAD RECEIVED THE REPORT AND ADMINISTERED AN ANTIBIOTIC EFFECTIVE IN TREATING THE PATIENT'S ESCHERICHIA COLI (E. COLI) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608569 EXPANSE LABORATORY/MICROBIOLOGY EXPANSE LABORATORY/MICROBIOLOGY JQP MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE RELEASE 2.2 00863529000155

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Unknown Hospitalization| O