BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT MANAGERCALCULATOR/DATA PROCESSING MODUL

    MDR report key: 11701705 · Received April 20, 2021

    Report

    Report Number
    MW5100909
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 19, 2021
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ROCHE DIAGNOSTICS (A DISTRIBUTOR OF DATA INNOVATIONS' INSTRUMENT MANAGER SOFTWARE) REPORTED AN ISSUE TO DATA INNOVATIONS (DI) ON BEHALF OF (B)(6) ON (B)(6) 2021: AN INITIAL RESULT FOR A BHCG TEST (PREGNANCY TEST) WAS RECEIVED FROM THE ANALYZER WITH A RESULT VALUE OF '10000' AND ERROR CODE '26. THE SAMPLE WAS HELD BASED ON A CONFIGURATION SETTING AND THEN RERUN FOR DILUTION. THE NEXT RESULT RECEIVED WAS A BLANK RESULT FOR AN INSUFFICIENT SAMPLE, THE RESULT WAS HELD AGAIN, AND A CONFIGURATION VALUE CHANGED THE RESULT TO BE <1,000,000. WHILE THE RERUN WAS RUNNING, THE LAB TECH MANUALLY RELEASED THE ORIGINAL RESULT BEFORE THE DILUTION WAS COMPLETE. THIS WAS REPORTED AS A CRITICAL/POSITIVE RESULT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER. REPORT IS BEING SUBMITTED DUE TO DATA INNOVATIONS BECOMING AWARE THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588969 INSTRUMENT MANAGERCALCULATOR/DATA PROCESSING MODUL CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC V8.16.00

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization