BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 10152797 · Received June 15, 2020

    Report

    Report Number
    1319809-2020-00063
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 15, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS SODIUM ( NA+) RESULT WAS OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUID USING VITROS NA+ SLIDES LOT 4226-1024-4851 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS AN ISSUE RELATED TO THE CUSTOMER¿S PROTOCOL WHEN PREPARING THE VITROS PV FLUIDS AND THE VITROS CALIBRATOR KIT. THE CUSTOMER HAD USED A SINGLE USE MOUTH ASPIRATION PIPETTE IN AT LEAST ONE INSTANCE OF PREPARING PV FLUIDS AND VITROS CAL KIT 0219. ORTHO RECOMMENDS USING EITHER A CLASS A VOLUMETRIC PIPETTE OR AN AUTOMATED PIPETTE WHEN PREPARING THESE FLUIDS. A SUBOPTIMAL CALIBRATION COULD NOT BE CONFIRMED NOR RULED OUT AS A CAUSE OF THE EVENT AS THE PARAMETERS OF THE CALIBRATION FROM THE DAY OF THE EVENT WERE DETERMINED TO BE ATYPICAL. HOWEVER, ACCEPTABLE QC RESULTS WERE OBTAINED USING THESE CALIBRATION PARAMETERS AFTER FRESH VIALS OF VITROS PV FLUIDS WERE PROCESSED. THE CAUSE OF THE SUBOPTIMAL CALIBRATION WAS MOST LIKELY RELATED TO IMPROPER PROTOCOL DURING THE RECONSTITUTION PROCESS. A VITROS NA+ REAGENT LOT 4226-1024-4851 RELATED ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT AS HISTORICAL QUALITY CONTROL RESULTS WERE NOT ACCEPTABLE. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NA+ REAGENT LOT 4226-1024-4851. ALTHOUGH PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT AS THE ISSUE WAS RESOLVED WITHOUT ANY ACTIONS BEING TAKEN TO TROUBLESHOOT THE ANALYZER. HOWEVER, BECAUSE WITHIN LABORATORY IMPRECISION WAS SEEN WITH THE HISTORICAL QC RESULTS AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS SODIUM ( NA+) RESULT FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUID USING VITROS NA+ SLIDES LOT 4226-1024-4851 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV I F6662 RESULT OF 145.5 MMOL/L VS. THE EXPECTED RESULT OF 118.1 MMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS NA+ RESULT WAS GENERATED FROM A NON-PATIENT FLUID, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620000 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTIC JGS ORTHO-CLINICAL DIAGNOSTICS 4226-1024-4851

    Patients

    Seq Age Sex Outcome Treatment
    1