BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 17613778 · Received August 24, 2023

    Report

    Report Number
    0001319809-2023-00075
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JGS
    UDI-DI
    10758750004812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) SLIDE LOT 4210-1095-5242 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1101-1047 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI CORE (MAS) LOT OCR2511 CONTROL TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS NA+ RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM VITROS NA+ SLIDE LOT 4210-1095-5242 WERE INACCURATE AND IMPRECISE, INDICATING THE VITROS NA+ SLIDES WERE NOT PERFORMING AS INTENDED ON THE VITROS 5600 INTEGRATED SYSTEM. THEREFORE, A REAGENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ SLIDE LOT 4210-1095-5242. IT IS POSSIBLE THAT IMPROPER PRE-ANALYTICAL FLUID HANDLING OR AN ISSUE RELATED TO THE MAS LEVEL 1 CONTROL CONTRIBUTED TO THE EVENT HOWEVER, THIS CANNOT BE CONFIRMED. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS K+ RESULTS WAS AN ATYPICAL CALIBRATION DUE TO USER ERROR. THE CALIBRATION RESPONSES AND PARAMETERS APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. IT WAS DETERMINED THE CUSTOMER WAS USING IMPROPER RECONSTITUTION OF THE VITROS CALIBRATOR LOT 0272 FLUIDS. THE CUSTOMER USED A 1 ML VOLUMETRIC PIPETTE TO ADD 3 ML OF REQUIRED DILUENT TO THE CALIBRATOR LYOPHILATES. THIS IS OUTSIDE THE ORTHO RECOMMENDATION OF USING A 3 ML VOLUMETRIC PIPETTE TO RECONSTITUTE THE CALIBRATORS. THEREFORE, IMPROPER FLUID HANDLING PROTOCOL LIKELY CONTRIBUTED TO THE HIGHER RESULTS ASSOCIATED WITH THOSE CALIBRATIONS. EXPECTED VITROS K+ RESULTS WERE OBTAINED WHEN AN ALTERNATE SET OF VITROS CALIBRATOR KIT LOT 0272 FLUIDS WERE RECONSTITUTED USING A 3 ML VOLUMETRIC PIPETTE. NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM, THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) SLIDE LOT 4210-1095-5242 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1101-1047 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI CORE (MAS) LOT OCR2511 CONTROL TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 1 NA+ RESULTS OF 135.2 AND 167.2 MMOL/L VS. THE EXPECTED RESULT OF 127.7 MMOL/L THE MAS LEVEL 1 K+ RESULT OF 6.69 MMOL/L VS. THE EXPECTED RESULT OF 2.67 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS(B)(4) AND REPORTABILITY ASSESSMENT 602912.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201254 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 4210-1095-5242 10758750004812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown