BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK

    MDR report key: 24581750 · Received March 12, 2026

    Report

    Report Number
    3007111389-2026-00045
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 12, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DDR
    UDI-DI
    10758750001019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT NEGATIVELY BIASED VITROS MYOG RESULTS WERE OBTAINED FROM NON-VITROS BIORAD LOT 1003110 LEVEL 1 QUALITY CONTROL FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS MYOG REAGENT LOT 2670, ON A VITROS XT7600 INTEGRATED SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. QUALITY CONTROL RESULTS OBTAINED USING THE BIORAD CONTROLS DETERMINED THAT INTERMITTENT ACCEPTABLE AND UNACCEPTABLE PERFORMANCE WAS OBTAINED WITHIN THE TIMEFRAME OF THE EVENT. THEREFORE, A REAGENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IN ADDITION, THE REAGENT PACK IN USE GENERATED AN EXPIRED ON-BOARD STABILITY CODE, INDICATING THE CUSTOMER WAS NOT FOLLOWING ORTHO SPECIFICATIONS FOR REAGENT PACK HANDLING. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS MYOG REAGENT LOT 2670. NO INFORMATION WAS PROVIDED CONCERNING THE SAMPLE HANDLING OF THE BIORAD CONTROLS. IN ADDITION, THERE WERE FOUR OTHER ASSAYS HAVING ISSUE WITH THE BIORAD QC PERFORMANCE. THEREFORE, INCONSISTENT PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A PERFORMANCE ISSUE WITH THE VITROS XT7600 INTEGRATED SYSTEM COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT AS THERE WAS NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NEGATIVELY BIASED VITROS MYOGLOBIN (MYOG) RESULTS OBTAINED FROM NON-VITROS BIORAD LOT 1003110 LEVEL 1 QUALITY CONTROL FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS MYOG REAGENT LOT 2670, ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LOT 1003110 L1 VITROS MYOG RESULTS OF 110.9, 110.6 AND 113.0 NG/ML VS. THE EXPECTED VITROS MYOG VALUE OF 130 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571588 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK IN-VITRO DIAGNOSTICS DDR ORTHO-CLINICAL DIAGNOSTICS 2670 10758750001019

    Patients

    Seq Age Sex Outcome Treatment
    1