BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2220939 · Received August 23, 2011

    Report

    Report Number
    1319681-2011-00165
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A VITROS CEA REAGENT PACK HAD BEEN MISIDENTIFIED AS A VITROS FT4 REAGENT PACK. NO BIASED OR ERRONEOUS RESULTS WERE OBTAINED AS THE FT4 ASSAY SIGNAL OBTAINED FROM THE MISIDENTIFIED CEA REAGENT PACK WAS BELOW THE FT4 MINIMUM ASSAY THRESHOLD LIMIT; THEREFORE CONDITION CODE PW8-405 (ALU TO SMALL) WAS GENERATED. HOWEVER, IT IS POSSIBLE BIASED AND BELIEVABLE RESULTS CAN BE OBTAINED IF CERTAIN COMBINATIONS OF MISIDENTIFIED REAGENT PACKS ARE INVOLVED. THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR WHILE LOADING AND MANUALLY IDENTIFYING A VITROS IMMUNODIAGNOSTICS REAGENT PACK.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO TEST TWO DIFFERENT PATIENT SAMPLES USING A VITROS FREE T4 (FT4) REAGENT PACK ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, NO RESULT WAS GENERATED FOR EITHER SAMPLE. THE VITROS ECIQ SYSTEM INSTEAD POSTED PW8-405 (ALU TO SMALL) CONDITION CODES. THE PW8-405 CONDITION CODE INDICATES THE FT4 ASSAY SIGNAL IS BELOW THE MINIMUM THRESHOLD FOR THE ASSAY. IT WAS LATER DETERMINED A VITROS CEA REAGENT PACK HAD BEEN MISIDENTIFIED AS A VITROS FT4 REAGENT PACK. NO BIASED OR ERRONEOUS RESULTS WERE OBTAINED USING THE MISIDENTIFIED REAGENT PACK. HOWEVER, DEPENDING ON THE COMBINATION OF MISIDENTIFIED REAGENT PACKS INVOLVED, BIASED AND BELIEVABLE RESULTS COULD BE OBTAINED AND REPORTED FROM THE LABORATORY IF OCCURRED UNDETECTED. BIASED RESULTS OBTAINED FROM A REAGENT PACK OTHER THAN THE INTENDED REAGENT PACK MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1