BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 8696997 · Received June 13, 2019

    Report

    Report Number
    1319808-2019-00015
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VANC RESULT WAS OBTAINED AS PART OF A VANC CORRELATION STUDY WITH ANOTHER SITE USING A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS VANC RESULT. THE CUSTOMER RESTORED THE CALIBRATION PARAMETERS OBTAINED ON (B)(6) AND REPROCESSED THE PATIENT SAMPLE OBTAINING AN ACCEPTABLE RESULT. RESTORING THE PREVIOUS CALIBRATION TO RESOLVE THE ISSUE SUGGESTS THE CAUSE OF THE LOW RESULT WAS RELATED TO A SUBOPTIMAL CALIBRATION. HOWEVER, THE VITROS VANC QUALITY CONTROL RESULTS GENERATED AFTER THE (B)(6) CALIBRATION WERE WITHIN THE EXPECTED RANGE INDICATING ACCEPTABLE ACCURACY, WHICH RULES OUT A SUBOPTIMAL CALIBRATION AS THE CAUSE OF THE LOWER THAN EXPECTED RESULT. THE ACCEPTABLE VITROS VANC QUALITY CONTROL RESULTS INDICATE THAT VITROS VANC LOT 2514-38-7130 IS PERFORMING AS EXPECTED. IN ADDITION, THE ACCEPTABLE WITHIN RUN PRECISION TEST INDICATES THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED AND IS NOT A CONTRIBUTOR TO THE EVENT. THE LIKELY CAUSE OF THE LOWER THAN EXPECTED VITROS VANC RESULT IS A PRE-ANALYTICAL FLUID HANDLING ISSUE WHEN PERFORMING THE PATIENT CORRELATION. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON HOW THE SAMPLE WAS HANDLED PRIOR TO TESTING, THEREFORE ALTHOUGH PRE-ANALYTICAL FLUID HANDLING IS THE LIKELY CAUSE, IT CANNOT BE DEFINITIVELY PROVEN. THE LOWER THAN EXPECTED VITROS VANC RESULT WAS OBTAINED WHEN PERFORMING A PATIENT CORRELATION WITH ANOTHER VITROS SITE. THE LOWER THAN EXPECTED VITROS VANC RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED.

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VANC RESULT WAS OBTAINED WHEN PROCESSING ONE PATIENT SAMPLE DURING A CORRELATION WITH ANOTHER VITROS SITE USING A VITROS 5600 INTEGRATED SYSTEM. THE MAGNITUDE AND DIRECTION OF BIAS OBSERVED MET VANC POTENTIAL HEALTH AND SAFETY CRITERIA. PATIENT SAMPLE, VITROS VANC RESULT 8.4* UG/ML VERSUS THE EXPECTED VITROS VANC RESULT 15.30 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE PATIENT SAMPLE RESULT IN QUESTION WAS OBTAINED AS PART OF A VANC CORRELATION STUDY WITH ANOTHER SITE AND NO PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491771 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-38-7130

    Patients

    Seq Age Sex Outcome Treatment
    1