BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 4218144 · Received October 31, 2014

    Report

    Report Number
    1319809-2014-00052
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    June 14, 2014
    Report Date
    November 25, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    - THE VITROS PHYT REAGENT LOT WAS PREVIOUSLY REPORTED AS UNKNOWN FOR CET-02 VITROS RESULT. THE VITROS PHYT REAGENT LOT IS UPDATED TO 2613-0143-7904. - THE VITROS PHYT REAGENT LOT WAS PREVIOUSLY REPORTED AS 2613-0149-3770 FOR CET-06, CET-07, CET-09 AND TDM L2 SAMPLE RESULTS. THE VITROS PHYT REAGENT LOT IS UPDATED TO 2613-0146-1212. THE NARRATIVE OF THE ORIGINAL EMDR HAD A CLERICAL ERROR IN REPORTING THE INCORRECT TDM L2 QC RESULT OF 19.75 ¿G/ML. HAS BEEN UPDATED TO TDM L2 QC RESULT OF 19.77 ¿G/ML. THE ORIGINAL INDICATED THE TDM L2 EXPECTED RESULT WAS 15.1 ¿G/ML. UPDATED SO THE TDM L2 EXPECTED RESULT IS 15.83 ¿G/ML. T ORIGINAL EMDR WAS WRITTEN AS "HOWEVER A TRANSIENT ISSUE RELATED TO THE VITROS PHYT REAGENT LOT 2613-0149-3770 IN USE AT THE TIME CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR". THE STATEMENT SHOULD BE UPDATED WITH THE CORRECT VITROS PHYT LOT NUMBERS TO STATE "HOWEVER A TRANSIENT ISSUE RELATED TO THE VITROS PHYT REAGENT LOTS 2613-0143-7904 AND 2613-0146-1212 IN USE AT THE TIME OF EACH EVENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS". USER ERROR ASSOCIATED WITH THE USE OF EXPIRED QUALITY CONTROL MATERIAL CANNOT BE RULED OUT AS AN ADDITIONAL CONTRIBUTING FACTOR.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FOR MULTIPLE PROFICIENCY SAMPLES AND A VITROS TDM QUALITY CONTROL RUN ON A VITROS 350 CHEMISTRY SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER A TRANSIENT ISSUE RELATED TO THE VITROS PHYT REAGENT LOT 2613-0149-3770 IN USE AT THE TIME CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. IN ADDITION, SINCE THE INSTRUMENT¿S PERFORMANCE (I.E. PRECISION TESTING) WAS NOT EVALUATED AT THE TIME THE EVENT OCCURRED, AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LOWER THAN EXPECTED VITROS PHYT RESULTS FOR MULTIPLE PROFICIENCY SAMPLES AND A VITROS TDM QUALITY CONTROL RUN ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PHYT REAGENT LOT: UNKNOWN, CET-02 VITROS RESULT 28.0 VERSUS EXPECTED 6.9 ¿G/ML; VITROS PHYT REAGENT LOT: 2613-0149-3770, CET-06 VITROS RESULT 33.5 VERSUS EXPECTED 24.0 ¿G/ML, CET-07 VITROS RESULT 28.0 VERSUS EXPECTED 21.6 ¿G/ML, CET-09 VITROS RESULT 22.5 VERSUS EXPECTED 18.3 ¿G/ML, TDM L2 VITROS RESULT 19.75 VERSUS EXPECTED 15.1 ¿G/ML. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED. HOWEVER, A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED WITH A PATIENT SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 4 OF 5 MDR¿S FOR THIS EVENT. FIVE (5) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. (B)(4).

    Description of Event or Problem · 1

    VITROS PHYT REAGENT LOT: 2613-0143-7904. CET-02 VITROS RESULT 28.0 VERSUS EXPECTED 6.9 ML. VITROS PHYT REAGENT LOT: 2613-0146-1212 TDM L2 VITROS RESULTS 19.77. VERSUS EXPECTED 15.83 ML

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699807 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2613-0146-1212

    Patients

    Seq Age Sex Outcome Treatment
    1