BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 18830910 · Received March 4, 2024

    Report

    Report Number
    1319809-2024-00027
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    January 18, 2024
    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 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 (CL2024-139) 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 HAS DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID AND A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4225-1110-2372 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 FROM VITROS PERFORMANCE VERIFIERS, A VITROS NA+ LOT 4225-1110-2372 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENTS. THE RESULTS OF DIAGNOSTIC PRECISION TESTING PERFORMED ON THE VITROS XT 7600 SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES, HOWEVER, THE TESTING WAS NOT PERFORMED AROUND THE TIMEFRAME OF THE EVENTS. ADDITIONALLY, HISTORICAL QUALITY CONTROL RESULTS FROM VITROS PV FLUIDS WERE IMPRECISE. THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENTS. A SAMPLE RELATED ISSUE CAN BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS THE ORTHO LS CONFIRMED THAT THE CUSTOMER WAS FOLLOWING PROPER FLUID PREPARING AND HANDLING PROTOCOL. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THE HIGHER THAN EXPECTED RESULTS WERE NOT DUE TO SAMPLE FLUID MIX-UP. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4225-1110-2372.

    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 IS NUMBER TWO OF THREE MDRS 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 400166922 AND REPORTABILITY ASSESSMENT 605195.

    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 FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID AND A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4225-1110-2372 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 89710 LEVEL 2 RESULTS OF 136.4 AND 136.6 MMOL/L VS AN EXPECTED RESULT OF 124.0 MMOL/L VITROS PV I LOT Q1174 RESULT OF 149.8 MMOL/L VS AN EXPECTED RESULT OF 117.1 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 HIGHER THAN EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER STATED THAT NO PATIENT SAMPLE RESULTS HAVE BEEN QUESTIONED. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS 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
    680118 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 4225-1110-2372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown