BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1319681-2017-00049

    MDR report key: 6671494 · Received June 27, 2017

    Report

    Report Number
    1319681-2017-00049
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 27, 2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VALP RESULT WAS OBTAINED FROM A VITROS PERFORMANCE VERIFIER QUALITY CONTROL FLUID PROCESSED USING VITROS VALP REAGENT WITH A VITROS 4600 CHEMISTRY SYSTEM. THERE IS NO INDICATION A REAGENT ISSUE CONTRIBUTED TO THE EVENT. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED. THE RESULTS OF PRE-SERVICE WITHIN-RUN PRECISION TESTING DEMONSTRATED THAT THE VITROS SYSTEM WAS NOT OPERATING AS EXPECTED AT THE TIME OF THE EVENT. AN ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS TO ADJUST THE CUVETTE INCUBATOR & METERING TRUCKS AND CLEAN RESIDUE FROM THE READ CHANNEL. THE VALP QUALITY CONTROL RESULTS OBTAINED AFTER SERVICE INDICATE ACCEPTABLE PERFORMANCE HAS BEEN MAINTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULT FROM A VITROS PERFORMANCE VERIFIER QUALITY CONTROL FLUID (LOT D5002= 134.2 VS. EXPECTED 111.5 UG/ML) USING VITROS VALP REAGENT IN COMBINATION WITH A VITROS 4600 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VALP RESULT WAS GENERATED FROM A NON-PATIENT FLUID, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1913621 / IVD 407462.

    Patients

    Seq Age Sex Outcome Treatment
    1