BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 10116307 · Received June 3, 2020

    Report

    Report Number
    1319808-2020-00023
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    April 17, 2020
    Report Date
    June 3, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS AND A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-27-7325 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. THE CUSTOMER IS FOLLOWING THE RECOMMENDED FLUID HANDLING PROTOCOL FOR THE MAS QC, THEREFORE, AN ISSUE WITH THE QC FLUIDS IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. A VITROS VALP REAGENT PACK ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT AS THE ISSUE OCCURRED ON MULTIPLE PACKS. SUBOPTIMAL CALIBRATIONS ARE NOT A LIKELY CAUSE OF THE EVENT AS THE CUSTOMER WAS ABLE TO PROCESS QC SUCCESSFULLY FOLLOWING EACH CALIBRATION. ADDITIONALLY, THE CALIBRATION PARAMETERS FOR EACH CALIBRATION EVENT APPEARED TYPICAL WHEN COMPARED TO DATABASE VALUES. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-27-7325. HOWEVER, HISTORICAL QUALITY CONTROL RESULTS OBTAINED USING VITROS VALP REAGENT LOT 2511-27-7325 WERE NOT ACCEPTABLE AND THEREFORE, A REAGENT RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. THE RESULTS FROM A VITROS GENT DIAGNOSTIC PRECISION TEST AND A VITROS VALP WITHIN RUN PRECISION TEST PERFORMED BY THE CUSTOMER ON THE VITROS 5600 INTEGRATED SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES INDICATING AN INSTRUMENT ISSUE IS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS FROM NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS AND A HIGHER THAN EXPECTED RESULT FROM A PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. MAS CHEMTRACKH ASSAYED QC L1 LOT CHA20111A VITROS VALP RESULT OF 103.1 UG/ML VS. THE EXPECTED RESULT OF 131.5 UG/ML. MAS CHEMTRACKH ASSAYED QC L3 LOT CHA20113A VITROS VALP RESULTS OF 12.5, 14.7 AND 15.9 UG/ML VS. THE EXPECTED RESULT OF 26.0 UG/ML. VITROS VALP PATIENT SAMPLE RESULT OF 56.6 UG/ML VERSUS AN EXPECTED RESULT OF 45.2 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED RESULTS WERE FROM QUALITY CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS OBTAINED DURING A PATIENT CORRELATION PERFORMED AS PART OF TROUBLESHOOTING. THE INVESTIGATION WAS UNABLE TO CONFIRM THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 1 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581109 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-27-7325

    Patients

    Seq Age Sex Outcome Treatment
    1