BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 2339413 · Received November 16, 2011

    Report

    Report Number
    1319808-2011-00039
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    October 28, 2011
    Report Date
    November 16, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, FALSE NEGATIVE VITROS OP RESULT WAS OBTAINED FOR A KNOWN POSITIVE QUALITY CONTROL FLUID. PATIENT SAMPLES WERE NOT KNOWN TO HAVE BEEN AFFECTED. THE CUSTOMER RECALIBRATED THEIR IN-USE VITROS OP REAGENT LOT, AND ACCEPTABLE PERFORMANCE WAS OBTAINED FOLLOWING RECALIBRATION. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, A CONTROL FLUID ISSUE AND/OR AN EQUIPMENT OR REAGENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, NEGATIVE VITROS OP RESULT FOR A KNOWN POSITIVE QUALITY CONTROL FLUID PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED WITH A PATIENT SAMPLE. NO PATIENT RESULTS WERE KNOWN TO HAVE BEEN AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITRO DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-06-1506

    Patients

    Seq Age Sex Outcome Treatment
    1