BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9

    MDR report key: 19617854 · Received June 26, 2024

    Report

    Report Number
    1319808-2024-00017
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 25, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIT
    UDI-DI
    10758750005031
    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 DETERMINED THAT A HIGHER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULT WAS OBTAINED FROM A SINGLE COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOT 2511-0107-8229 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS A SUBOPTIMAL CALIBRATION; HOWEVER, THE CAUSE OF THE SUBOPTIMAL CALIBRATION COULD NOT BE DETERMINED. CALIBRATION RESPONSES AND PARAMETERS WERE ATYPICAL WHEN COMPARED TO EXPECTED RESPONSES AND PARAMETERS. IN ADDITION, THE ACCEPTABLE VITROS PHBR RESULTS OBTAINED FROM THREE OF THE FOUR CAP SAMPLES WERE AT THE HIGH END OF THE ACCEPTABLE RANGE, AND HISTORIC QUALITY CONTROL RESULTS OBTAINED FROM ONE OF TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER FLUIDS WERE HIGH OUTSIDE THE ESTABLISHED VITROS RANGE OF MEANS. AN INSTRUMENT-RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS ACCEPTABLE VITROS PHBR PERFORMANCE WAS OBTAINED USING AN ALTERNATE VITROS PHBR SLIDE LOT WITHOUT PERFORMING ANY ACTIONS TO OPTIMIZE THE VITROS XT 7600 SYSTEM. IN ADDITION, THE RESULTS OF DIAGNOSTIC VITROS CRBM PRECISION TESTING, USED TO ASSESS INSTRUMENT PERFORMANCE, WERE WITHIN ACCEPTABLE GUIDELINES. HOWEVER, AS THE PRECISION TESTING WAS NOT PERFORMED WITHIN THE TIMEFRAME OF THE EVENT, A TRANSIENT ISSUE WITH THE VITROS XT 7600 SYSTEM CANNOT BE ENTIRELY RULE OUT AS A CONTRIBUTOR OF THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PHBR SLIDE LOT 2511-0107-8229.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS PHENOBARBITAL (PHBR) RESULT WAS OBTAINED FROM A SINGLE COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SURVEY SAMPLE WHEN PROCESSED USING VITROS PHBR SLIDE LOT 2511-0107-8229 ON A VITROS XT 7600 INTEGRATED SYSTEM. PROFICIENCY SAMPLE CHM-05 RESULT OF 32.0 VS. THE CAP PEER TARGET 25.97 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 HIGHER THAN EXPECTED VITROS PHBR RESULT WAS OBTAINED FROM A NON-PATIENT PROFICIENCY SAMPLE. NO VITROS PHBR PATIENT RESULTS HAVE BEEN QUESTIONED BY THE CUSTOMER AND 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
    640390 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9 IN-VITRO DIAGNOSTICS JIT ORTHO-CLINICAL DIAGNOSTICS, INC. 0952 10758750005031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown