BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 20913557 · Received December 12, 2024

    Report

    Report Number
    3007111389-2024-00232
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 11, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750002504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING A VITROS TROPI ES REAGENT LOT 5530 ON A XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED FOR THE SAME PATIENT SAMPLE USING NON-VITROS ABBOTT, BECKMAN AND VIDAS METHODS. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORICAL VITROS TROPI ES QUALITY CONTROL PERFORMANCE WAS WITHIN EXPECTATION FOR THE SINGLE LEVEL OF FLUID THE CUSTOMER PROCESSES FOR VITROS TROPI ES. HOWEVER, AS THE CUSTOMER ONLY USES A SINGLE LEVEL OF CONTROL RESULTS ACROSS THE MEASURING RANGE ARE NOT ASSESSED. ADDITIONALLY, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT, OR BELOW THE URL. THEREFORE, THE PERFORMANCE OF THE VITROS TROPI ES REAGENT LOT 5530 AT, OR BELOW THE URL CONCENTRATION OF 0.034 NG/ML CANNOT BE DETERMINED AND A REAGENT ISSUE COULD NOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT. A VITROS TSH PRECISION TEST USING VITROS TOTAL THYROID CONTROL (TTC) LEVEL 2 WAS REQUESTED TO VERIFY THE PERFORMANCE OF THE VITROS XT 7600 SYSTEM. THE CUSTOMER INSTEAD PROCESSED A VITROS TSH3 PRECISION USING VITROS TTC LEVEL 1, HOWEVER THE CONCENTRATION OF THE FLUID WAS NOT SUFFICIENT TO PRODUCE A PRECISION GUIDELINE TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 SYSTEM. HOWEVER, THERE WAS NO INDICATION THAT THE VITROS XT 7600 SYSTEM MALFUNCTIONED AS THE RESULTS FROM VITROS TROPI ES, VITROS TROPI ES QC RESULTS PROVIDED WERE WITHIN EXPECTATION. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. ADDITIONALLY, THE CUSTOMER PROCESSED VITROS CK-MB (CREATININE KINASE-MB). PER THE VITROS CK-MB INSTRUCTIONS FOR USE (IFU): "VALUES OF LESS THAN 16 U/L SHOULD BE REPORTED AS NEGATIVE FOR CK-MB". THE RESULTS FROM THE PATIENT SAMPLE (6.0 AND 3.0 U/L) WERE BELOW THE CUTOFF OF 16 U/L, THEREFORE THE CK-MB RESULTS ARE IN AGREEMENT WITH THE NON-VITROS ABBOTT, BECKMAN AND VIDAS RESULTS (NEGATIVE FOR AMI). NO ADDITIONAL INTERFERENCE TESTING WAS PERFORMED AS REQUESTED ON THE PATIENT SAMPLE. THEREFORE, IT IS POSSIBLE THAT A SAMPLE INTERFERENT THAT AFFECTS VITROS TROPI ES ASSAYS BUT NOT THE NON-VITROS ABBOTT, BECKMAN AND VIDAS METHODS CONTRIBUTED TO THE HIGHER THAN EXPECTED RESULTS, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS TROPI ES LOT 5530.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING A VITROS TROPI ES REAGENT LOT 5530 ON A XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED FOR THE SAME PATIENT SAMPLE USING NON-VITROS ABBOTT, BECKMAN AND VIDAS METHODS. PATIENT 1 SAMPLE 1 VITROS TROPI ES RESULT OF 0.097 NG/ML (ABOVE THE AMI CUTOFF) VS AN EXPECTED RESULT OF NEGATIVE (ABBOTT RESULTS OF 0.001 NG/ML, BECKMAN RESULT OF 1.76 NG/L, VIDAS RESULT OF 1.5 NG/L) PATIENT 1 SAMPLE 2 VITROS TROPI ES RESULT OF 0.090 NG/ML (ABOVE THE AMI CUTOFF) VS AN EXPECTED RESULT OF NEGATIVE (ABBOTT RESULTS OF 0.001 NG/ML, BECKMAN RESULT OF 1.76 NG/L, VIDAS RESULT OF 1.5 NG/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 VITROS TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY AND NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON ANY VITROS RESULTS. THERE HAS BEEN 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) REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154239 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 5530 10758750002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown