BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10994816 · Received December 12, 2020

    Report

    Report Number
    1319681-2020-00122
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THREE DIFFERENT PATIENT SAMPLES B, C, AND D EACH CONTAINED THE INCORRECT PATIENT DEMOGRAPHICS ON THE RESULTS PRINT OUTS FROM A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS PRINT OUTS FOR PATIENT SAMPLES B, C, AND D EACH CONTAINED THE PATIENT DEMOGRAPHICS FROM AN ALTERNATE PATIENT ID (A). THE ASSIGNABLE CAUSE OF THE EVENT WAS CONCLUDED TO BE IMPROPER USE OF THE BATCH SAVE FEATURE ON THE VITROS 5600 INTEGRATED SYSTEM. WHILE THE OPERATOR WAS USING THE SAMPLE PROGRAM SCREEN, THE SAMPLE ID FOR PATIENT A WAS CALLED UP. THEY THEN USED THE BATCH SAVE FEATURE TO PROGRAM SAMPLES B, C, AND D. THE PATIENT DEMOGRAPHICS FOR PATIENT ID A WERE APPLIED TO EACH OF SAMPLES B, C, AND D AS PER FUNCTION OF THE BATCH SAVE FEATURE. AFTER THE SAMPLES WERE PROCESSED, THE RESULTS FOR PATIENT SAMPLES B, C, AND D ALL CONTAINED THE PATIENT DEMOGRAPHICS FOR PATIENT ID A ON THE PRINT OUTS FROM THE VITROS SYSTEM. THE ORTHO TECHNICAL SUPPORT CENTER REVIEWED WITH THE CUSTOMER THE PROPER WAY TO USE THE BATCH SAVE FEATURE WHEN PROGRAMMING MULTIPLE DIFFERENT PATIENT SAMPLES ON THE VITROS 5600 INTEGRATED SYSTEM. EMAIL ADDRESS FOR CONTACT OFFICE: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE DIFFERENT PATIENT SAMPLES B, C, AND D EACH CONTAINED THE INCORRECT PATIENT DEMOGRAPHICS ON THE RESULT PRINT OUTS FROM A VITROS 5600 INTEGRATED SYSTEM. THE RESULT PRINT OUTS FOR PATIENT SAMPLES B, C, AND D EACH CONTAINED THE PATIENT DEMOGRAPHICS FROM AN ALTERNATE PATIENT ID (A). INCORRECT PATIENT INFORMATION MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF IT WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO ERRONEOUS RESULTS WERE REPORTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459597 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1