BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 18057669 · Received November 2, 2023

    Report

    Report Number
    0001319809-2023-00128
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 1, 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 CONCLUDES THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED WHEN PROCESSING VITROS PERFORMANCE VERIFIER I, LOT Q1174 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE DEFINITIVE CAUSE COULD NOT BE CONFIRMED. A REVIEW OF HISTORICAL QC RESULTS PRIOR TO THE DAY OF THE EVENT INDICATED SOME PRECISION ISSUES USING VITROS NA+ LOT 4212-1097-6150. THEREFORE, A VITROS NA+ REAGENT ISSUE COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. AN ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE VITROS XT 7600 SYSTEM AND FOLLOWING SERVICE THE CUSTOMER OBTAINED ACCEPTABLE VITROS NA+ LOT 4212-1097-6150 RESULTS WITHOUT A RECALIBRATION. TWO DAYS AFTER THE SERVICE EVENT, A WITHIN RUN PRECISION WAS PERFORMED AND THE PRECISION RESULTS WERE ACCEPTABLE INDICATING THE VITROS XT7600 INTEGRATED SYSTEM WAS PERFORMING AS EXPECTED. HOWEVER, AS THERE WAS NO PRE-SERVICE PRECISION TEST PERFORMED TO ASSESS THE PERFORMANCE PRIOR TO SERVICE, AN ISSUE WITH THE VITROS XT7600 SYSTEM COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. A POSSIBLE CAUSE OF THE HIGHER THAN EXPECTED VITROS NA+ RESULTS WHEN PROCESSING PERFORMANCE VERIFIER I CONTROL FLUID IS A PRE-ANALYTICAL SAMPLE PROGRAMMING ERROR, HOWEVER, THIS COULD NOT BE DEFINITIVELY CONFIRMED. A REVIEW OF ECONNECTIVITY DATA SHOWS THE CUSTOMER ROUTINELY PROCESSES THE LEVEL 1 CONTROL IN THE MORNING AND THE LEVEL 2 CONTROL IN THE EVENING. IT IS SUSPECTED THE EVENING CUSTOMER PROGRAMMED THE LEVEL 2 CONTROL USING THE LEVEL 1 SAMPLE NAME ¿KOD1¿ IN ERROR. THE DATA SHOWS THE CUSTOMER REPEATED THE LEVEL 2 CONTROL CORRECTLY USING THE LEVEL 2 SAMPLE NAME OF KOD2 AND OBTAINED RESULTS REPRESENTATIVE OF A LEVEL 2 CONTROL.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED WHEN PROCESSING VITROS PERFORMANCE VERIFIER I, LOT Q1174 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PERFORMANCE VERIFIER I, LOT Q1174 RESULTS 139.5, 139.7, 144.0 MMOL/L VERSUS THE MIDPOINT OF THE RANGE OF MEANS (115.9 MMOL/L) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER DID NOT PROVIDE ANY EVIDENCE THAT PATIENT SAMPLE RESULTS WERE AFFECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER THREE 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216053 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 4212-1097-6150 10758750004812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown