BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 16225284 · Received January 23, 2023

    Report

    Report Number
    0001319808-2023-00002
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 26, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEH
    UDI-DI
    10758750006731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS LOT: CHA24080 CONTROL FLUIDS AND THE RESULTS OBTAINED FROM THE LEVEL 2 CONTROL MET POTENTIAL HEALTH AND SAFETY CRITERIA. THE RESULTS WERE OBTAINED ON A VITROS XT7600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS THE VITROS VANC REAGENT PACKS IN USE AT THE TIME OF THE EVENT. THE CUSTOMER STATED THAT DURING THE TIMEFRAME OF THIS EVENT, THE REFRIGERATOR WHERE THE VITROS MICROTIP REAGENTS WERE STORED, INCLUDING THE VITROS VANC REAGENT, MALFUNCTIONED, AND SOME REAGENT PACKS WERE FROZEN. IT IS POSSIBLE THE AFFECTED REAGENT PACKS WERE FROZEN. PER THE VITROS VANC INSTRUCTIONS FOR USE, ONLY REFRIGERATED STORAGE IS SPECIFIED AS ACCEPTABLE. A SYSTEMIC PERFORMANCE ISSUE VITROS VANC LOT: 2514-49-9851 DID NOT LIKELY CONTRIBUTE TO THE EVENT AS ACCEPTABLE VITROS VANC RESULTS WERE OBTAINED PRIOR TO THE EVENT USING ALTERNATE REAGENT PACKS OF THE SAME REAGENT LOT. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VANC LOT: 2514-49-9851. A PERFORMANCE ISSUE WITH THE VITROS XT7600 INTEGRATED SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT AS DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED AND THE RESULTS INDICATED THE VITROS XT7600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS MAS LOT: CHA24080 CONTROL FLUIDS AND THE RESULTS OBTAINED FROM THE LEVEL 2 CONTROL MET POTENTIAL HEALTH AND SAFETY CRITERIA. THE RESULTS WERE OBTAINED ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LEVEL 2 RESULTS OF <5.0 UG/ML (X3) VS. THE TARGET VALUE OF 32.0 UG/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. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY, THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454769 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 6801709 2514-49-9851 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown