BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 6709991 · Received July 13, 2017

    Report

    Report Number
    1319809-2017-00101
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FOR MULTIPLE QUALITY CONTROL FLUIDS AND PATIENT SAMPLES RUN ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN, HOWEVER, THE MOST LIKELY ASSIGNABLE CAUSE IS A NON-REACTIVE CARTRIDGE CAUSED BY HAVING THE INTEGRITY OF THE FOIL WRAPPER COMPROMISED AND EXPOSING THE SLIDES TO AMBIENT CONDITIONS, ALTHOUGH THIS COULD NOT BE CONFIRMED. FOR THE VITROS GLU ASSAY, A NON-REACTIVE CARTRIDGE CAUSES HIGHER THAN EXPECTED RESULTS. ACCEPTABLE GLU RESULTS WERE OBTAINED WHEN THE SAME SAMPLES WERE TESTED WITH AN ALTERNATE VITROS GLU SLIDE LOT 0030-0918-2862 CARTRIDGE, AND QUALITY CONTROL RESULTS PROCESSED ON ALTERNATE VITROS GLU SLIDE LOT 0030-0918-2862 CARTRIDGES PRIOR TO, AND AFTER THE EVENT WERE ACCEPTABLE. THIS WOULD INDICATE THE EVENT WAS ISOLATED TO THE AFFECTED VITROS GLU SLIDE LOT 0030-0918-2862 CARTRIDGE IN USE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS GLU RESULTS FOR MULTIPLE QUALITY CONTROL FLUIDS AND PATIENT SAMPLES RUN ON A VITROS 5600 INTEGRATED SYSTEM. (B)(6). 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 IS NUMBER 3 OF 33 MDR¿S FOR THIS EVENT. THIRTY-THREE (33) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 33 DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490309 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0030-0918-2862

    Patients

    Seq Age Sex Outcome Treatment
    1