BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 2112960 · Received June 3, 2011

    Report

    Report Number
    1319809-2011-00015
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU QUALITY CONTROL RESULT WAS OBTAINED. PERFORMANCE TESTING DEMONSTRATED THAT THE VITROS 250 SYSTEM WAS OPERATING AS EXPECTED. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT EITHER THE VITROS 250 OR THE VITROS GLU SLIDE REAGENT HAD MALFUNCTIONED. EXPECTED GLU RESULTS WERE OBTAINED FROM AN ALTERNATE VIAL OF FRESHLY PREPARED QUALITY CONTROL FLUID. NO INSTRUMENT REPAIR WAS REQUIRED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, USER ERROR IN PROCESSING AN INCORRECT SAMPLE FLUID CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS GLU RESULT (VITROS PV II <10 MG/DL VS. EXPECTED RESULT OF 287.1 MG/DL) FROM A SINGLE QUALITY CONTROL FLUID PROCESSED ON THE VITROS 250 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO RECUR UNDETECTED WITH PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0022-0793-4996

    Patients

    Seq Age Sex Outcome Treatment
    1