BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 7704871 · Received July 19, 2018

    Report

    Report Number
    1225673-2018-00006
    Event Type
    Injury
    Date Received
    July 19, 2018
    Report Date
    July 19, 2018
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    PMA / PMN Number
    BK120051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN DETERMINED THAT THIS WAS A USER ERROR. THIS WAS NOT AN INSTRUMENT MANAGER MALFUNCTION. THE CUSTOMER IS UNABLE TO DETERMINE (OR IS UNWILLING TO PROVIDE DI WITH THE INFORMATION IF THEY HAVE DETERMINED) IF ANY ACTUAL PATIENT HARM OCCURRED. BASED ON THE INFORMATION PROVIDED TO DI, DI CANNOT CONCLUSIVELY SAY THAT NO PATIENT HARM OCCURRED DURING THE DURATION OF TIME THE SYSTEM WAS MISCONFIGURED IN THIS MANNER, THEREFORE AN MDR WAS FILED PER 21 CFR 803.

    Description of Event or Problem · 0

    CUSTOMER HAS 5 FACILITIES USING MEDHOST SOFTWARE FOR THEIR 5 LABORATORY INFORMATION SYSTEMS (LIS'S). THEY USE DUPLICATE PATIENT ID'S ACROSS THE 5 SITES. WHEN A RESULT IS PROCESSED USING A PATIENT ID THAT HAS ALREADY BEEN USED, THE PATIENT DEMOGRAPHICS FOR THE SECOND INSTANCE MAY BE OVERWRITTEN WITH THE PATIENT DEMOGRAPHICS OF THE FIRST PATIENT. USING DUPLICATE PATIENT ID'S ACROSS THE ENTERPRISE IS NOT RECOMMENDED IN THE INSTRUMENT MANAGER USER MANUAL.

    Description of Event or Problem · 1

    CUSTOMER HAS 5 FACILITIES USING MEDHOST SOFTWARE FOR THEIR 5 LABORATORY INFORMATION SYSTEMS (LIS'S). THEY USE DUPLICATE PATIENT ID'S ACROSS THE 5 SITES. WHEN A RESULT IS PROCESSED USING A PATIENT ID THAT HAS ALREADY BEEN USED, THE PATIENT DEMOGRAPHICS FOR THE SECOND INSTANCE MAY BE OVERWRITTEN WITH THE PATIENT DEMOGRAPHICS OF THE FIRST PATIENT. USING DUPLICATE PATIENT ID'S ACROSS THE ENTERPRISE IS NOT RECOMMENDED IN THE INSTRUMENT MANAGER USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547047 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.14.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other