BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 4090270 · Received September 15, 2014

    Report

    Report Number
    1319809-2014-00048
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE RUN ON A VITROS 5600 CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THE INVESTIGATION DETERMINED THAT THE VITROS 5600 CHEMISTRY SYSTEM WAS OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE OF A VITROS GLU REAGENT MALFUNCTION BASED ON REVIEW OF RECENT QUALITY CONTROL DATA. PRE-ANALYTICAL SAMPLE HANDLING AND AN (B)(6) LAB AUTOMATION ROUTING ISSUE WERE RULED OUT AS CONTRIBUTING FACTORS. OUTSIDE OF THE ONE PATIENT SAMPLE IN QUESTION, NO FURTHER ISSUES HAVE BEEN NOTED WITH VITROS GLU PERFORMANCE AT THIS CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU RESULT FOR ONE PATIENT SAMPLE RUN ON A VITROS 5600 CHEMISTRY SYSTEM. PATIENT SAMPLE = 3.2 MMOL/L VERSUS EXPECTED 11.4 MMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE REPORTED OUTSIDE THE LABORATORY; HOWEVER, A CORRECTED REPORT WAS ISSUED ONCE REPEAT TESTING WAS COMPLETE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568871 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0010-0880-4764

    Patients

    Seq Age Sex Outcome Treatment
    1