BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 16880367 · Received May 5, 2023

    Report

    Report Number
    0001319809-2023-00033
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 10, 2023
    Report Date
    July 26, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JGS
    Removal / Correction Number
    1000305840/07162024/C/00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHO HAS CONFIRMED AN ISSUE INVOLVING VITROS XT CHEMISTRY PRODUCTS ALB-TP SLIDES WHICH MAY CREATE DUST AND DEBRIS WITHIN THE MICROSLIDE SUBSYSTEM ON VITROS XT 3400 CHEMISTRY SYSTEMS AND VITROS XT 7600 INTEGRATED SYSTEMS. DUST AND DEBRIS FROM XT ALB-TP SLIDES MAY IMPACT VITROS CHEMISTRY PRODUCTS NA+ SLIDES LEADING TO A POTENTIAL INCREASE IN NON-REPRODUCIBLE, POSITIVELY, OR NEGATIVELY BIASED NA+ RESULTS. THIS SUPPLEMENTAL MDR WAS CREATED TO ASSOCIATE THE ISSUE FOR DUST AND DEBRIS FROM VITROS XT ALB-TP SLIDES PROCESSED ON VITROS XT SYSTEMS AS A POTENTIAL CONTRIBUTOR TO THIS REPORTABLE EVENT. THE FDA WAS NOTIFIED OF THIS ISSUE ON 16 JULY 2024. PLEASE REFER TO REPORT #(B)(4). ORTHO SENT A NOTIFICATION (B)(4) TO CUSTOMERS ON 10 JULY 2024. THE NOTIFICATION INFORMED CUSTOMERS THAT ORTHO WILL BE PAUSING AVAILABILITY OF THE VITROS XT ALB-TP SLIDES AND WILL SHIFT ALL AFFECTED CUSTOMERS TO THE INDIVIDUAL VITROS CHEMISTRY PRODUCTS ALB SLIDES AND TP SLIDES. IN ADDITION, ORTHO PROVIDED RECOMMENDED CLEANING STEPS AND FREQUENCY OF CLEANING IN THE NOTIFICATION. UPDATED UDI NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4209-1094-5134 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4209-1094-5134 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT. AN INSTRUMENT RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEM. HOWEVER, HISTORICAL QC RESULTS WERE PRECISE AND THE RESULTS OF WITHIN RUN PRECISION TESTING PERFORMED ON THE INSTRUMENT WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4209-1094-5134.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO ASSOCIATE THIS REPORTABLE EVENT WITH AN ISSUE ORTHO HAS IDENTIFIED FOR DUST AND DEBRIS FROM VITROS XT ALB-TP SLIDES THAT MAY IMPACT VITROS NA+ SLIDES LEADING TO A POTENTIAL INCREASE IN NON-REPRODUCIBLE, POSITIVELY OR NEGATIVELY BIASED NA+ RESULTS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4209-1094-5134 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 149 MMOL/L VS AN EXPECTED RESULT OF 128 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601725.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195205 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 8379034 4209-1094-5134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown