BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12

    MDR report key: 21124559 · Received January 10, 2025

    Report

    Report Number
    1319808-2025-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 3, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    DLJ
    UDI-DI
    10758750006618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AS WELL AS FROM AN ADMIXTURE OF PATIENT SAMPLES AND INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ATTRIBUTABLE CAUSE OF THIS EVENT IS A SUBOPTIMAL CALIBRATION (CAL ID 188). THE CAUSE OF THE SUBOPTIMAL CALIBRATION COULD NOT BE DETERMINED. NO INFORMATION WAS PROVIDED BY THE CUSTOMER ABOUT HOW THE CALIBRATOR KITS WERE STORED OR HANDLED AND THEREFORE, A STORAGE OR HANDLING ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE SUBOPTIMAL CALIBRATION ON 22 APRIL 2024. UNACCEPTABLE, HIGHER THAN EXPECTED IQMH RESULTS WERE OBSERVED WHILE PROCESSING PROFICIENCY SURVEY FLUID ON CAL ID 188. HISTORICAL BIORAD QUALITY CONTROL RESULTS FOR VITROS VALP REAGENT LOT (B)(6) INDICATE THAT THE BIORAD QC RESULTS WERE POSITIVELY BIASED > 2 PEER SD FROM THE PEER MEAN, FURTHER INDICATING AN ACCURACY ISSUE (HIGH) ON CAL ID 188. IN ADDITION, THE CUSTOMER OBSERVED THE SAME POSITIVE BIAS ON CAL ID 188 WHILE PROCESSING AN ADMIXTURE OF PATIENT SAMPLES AND IQMH PROFICIENCY SAMPLES. LASTLY, VITROS VALP LOT 2511-33-2028 RESULTS PROCESSED WHILE USING BIORAD QC FLUID FOLLOWING RECALIBRATION EVENTS RECOVERED INTO ACCEPTABLE (PEER) RANGE, DEMONSTRATING FURTHER THAT A RECALIBRATION EVENT USING FRESH CALIBRATOR FLUID RESOLVED THE HIGHER-THAN-EXPECTED VITROS VALP RESULTS. A REVIEW OF HISTORICAL QUALITY CONTROL RESULTS FOR VITROS VALP REAGENT LOT 2511-33-2028 INDICATE THAT THE BIORAD QC RESULTS WERE INACCURATE AND IMPRECISE LEADING UP TO THE DAY OF THE EVENT, HOWEVER, A RECALIBRATION EVENT USING FRESH CALIBRATOR FLUID YIELDED BIORAD QC RESULTS WITHIN 2 PEER SD OF THE BIORAD NOVEMBER PEER MEAN. IN ADDITION, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VALP REAGENT LOT 2511-33-2028. THIS DEMONSTRATES THAT A VITROS VALP REAGENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ALTHOUGH WITHIN-RUN DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED ON THE VITROS XT7600 SYSTEM, AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS ACCEPTABLE VITROS VALP RESULTS WERE OBTAINED USING SUBSEQUENT CALIBRATIONS WITH NO ACTIONS PERFORMED ON THE INSTRUMENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AS WELL AS FROM AN ADMIXTURE OF PATIENT SAMPLES AND INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLES USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. IQMH/PATIENT SAMPLE ADMIXTURE 1 RESULT OF 404? MOL/L VERSUS THE EXPECTED REPEAT RESULT OF 331? MOL/L IQMH/PATIENT SAMPLE ADMIXTURE 6 RESULT OF 471? MOL/L VERSUS THE EXPECTED REPEAT RESULT OF 383? MOL/L BIORAD QC LEVEL 2 RESULTS 649, 620, 623, 631, 638, AND 639 UMOL/L WHEN COMPARED TO THE BR LEVEL 2 PEER MEAN OF 515.7 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED RESULTS WERE FROM AN ADMIXTURE OF IQMH PROFICIENCY SAMPLES AND PATIENT SAMPLES AND THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416546 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12 IN-VITRO DIAGNOSTICS DLJ ORTHO-CLINICAL DIAGNOSTICS, INC. 1213 10758750006618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown