BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS ACET SLIDES

    MDR report key: 23821474 · Received December 16, 2025

    Report

    Report Number
    1319809-2025-00101
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LDP
    UDI-DI
    10758750008339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS ACETAMINOPHEN (ACET) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE INITIAL RESULT FROM THE SAME PATIENT SAMPLE. A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED GIVEN THE LIMITED INFORMATION PROVIDED. THE CUSTOMER DID NOT PROVIDE BASELINE MEAN/SD VALUES, PACKAGE INSERT (PI) VALUES, AND/OR RANDOX PEER VALUES TO THE ORTHO TSC WHEN REQUESTED. THIS INFORMATION WOULD BE USED TO EVALUATE THE CUSTOMERS HISTORIC VITROS ACET QUALITY CONTROL (QC) RESULTS LEADING UP TO THE DAY OF THE EVENT. AS THIS INFORMATION WAS NOT PROVIDED, HISTORIC QC RESULTS WERE UNABLE TO BE EVALUATED. THEREFORE, A VITROS ACET SLIDE LOT 2918-0077-1305 PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS ACET SLIDE LOT 2918-0077-1305. AS OF THE DATE OF WRITING THIS REPORT, NO VITROS ALKP DIAGNOSTIC PRECISION TESTING HAS BEEN PERFORMED; THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. PRE-ANALYTICAL SAMPLE MIX-UP WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS A REVIEW OF THE SAMPLE VISCOSITIES AND ZEE-HEIGHT MEASUREMENTS SHOWED CONSISTENT RESULTS BETWEEN THE INITIAL AND REPEAT OF SAMPLE 1, INDICATING THAT THE SAME SAMPLE WAS PROCESSED. IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE COLLECTION DEVICE MANUFACTURERS SPECIFICATIONS FOR CENTRIFUGATION, THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS ACETAMINOPHEN (ACET) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE INITIAL RESULT FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE 1 VITROS ACET REPEAT RESULT OF < 2.0 MG/DL VS. THE INITIAL RESULT OF > 20.0 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS ACET RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE HAS BEEN NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 612879.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445890 VITROS CHEMISTRY PRODUCTS ACET SLIDES IN-VITRO DIAGNOSTICS LDP ORTHO-CLINICAL DIAGNOSTICS, INC. 2918-0077-1305 10758750008339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown