BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS HBA1C REAGENT

    MDR report key: 23809912 · Received December 15, 2025

    Report

    Report Number
    1319808-2025-00037
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    PDJ
    UDI-DI
    10758750030729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS CONCLUDED THAT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. DIAGNOSTIC VITROS GENT WITHIN-RUN PRECISION TESTING TO ASSESS INSTRUMENT PERFORMANCE WAS NOT PROCESSED, THEREFORE, AN ANALYZER PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HISTORIC QUALITY CONTROL RESULTS OBTAINED FROM VITROS HBA1C REAGENT LOT 1519-46-3073 SHOWED SOME IMPRECISION, THEREFORE, A REAGENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. ACCEPTABLE PERFORMANCE WAS OBTAINED USING TWO ALTERNATE LOTS WITH THE SAME QC FLUIDS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS REAGENT LOT 1519-46-3073.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS HBA1C REAGENT LOT 1519-46-3073 RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD LIQUICHEK DIABETES LOT 89290 CONTROLS ON A VITROS XT 7600 SYSTEM. BIORAD LEVEL 1 VITROS HBA1C RESULTS OF 6.30, 6.35 AND 6.32 % NGSP VS. THE BASELINE MEAN OF 5.24 % NGSP. BIORAD LEVEL 2 VITROS HBA1C RESULTS OF 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 AND 10,51 % NGSP VS. THE BASELINE MEAN OF 8.39 % NGSP. 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 HBA1C RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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
    272385 VITROS CHEMISTRY PRODUCTS HBA1C REAGENT IN-VITRO DIAGNOSTICS PDJ ORTHO-CLINICAL DIAGNOSTICS, INC. 2535-46-3073 10758750030729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown