BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS TOBRA REAGENT

    MDR report key: 15297162 · Received August 25, 2022

    Report

    Report Number
    1319808-2022-00018
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 14, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS TOBRA RESULTS WERE OBTAINED FROM MULTIPLE SAMPLES (LINEARITY AND AN UNKNOWN FLUID) PROCESSED USING A VITROS 5,1 FS SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED. HOWEVER, USER ERROR IS A CONTRIBUTOR AS THE CUSTOMER IS DILUTING FLUIDS THAT PRODUCED RESULTS WITHIN THE VITROS TOBRA MEASURING RANGE. PER THE VITROS TOBRA INSTRUCTIONS FOR USE (IFU), MANUAL SAMPLE DILUTION CAN BE PERFORMED IF TOBRA CONCENTRATIONS EXCEED THE SYSTEM¿S MEASURING (REPORTABLE) RANGE. AS NONE OF THE SAMPLES WERE OUTSIDE OF THE VITROS TOBRA REPORTABLE RANGE (0.60¿10.00), THE SAMPLES SHOULD NOT HAVE BEEN DILUTED PRIOR TO TESTING. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT AS A REVIEW OF VOLUME PREDICTIONS FROM BOTH MANUAL AND ON-BOARD DILUTIONS INDICATED EXCESS SAMPLE IS BEING ADDED TO REAGENT FOR ON-BOARD DILUTED SAMPLE VS. SAMPLE RECOVERED FROM ANALYZER FOLLOWING MANUAL DILUTION. AT THIS TIME, DIAGNOSTIC WITHIN-RUN PRECISION TESTING USED TO ASSESS INSTRUMENT PERFORMANCE HAS NOT BEEN PERFORMED TO VERIFY THE ON-BOARD DILUTION PERFORMANCE. SERVICE ACTIONS PERFORMED BY AN ORTHO FIELD ENGINEER DID NOT RESOLVE THE ISSUE WITH HIGHER THAN EXPECTED RESULTS OBTAINED FROM SAMPLES DILUTED USING THE ON-BOARD DILUTION. HOWEVER, THE POST-SERVICE TESTING WITH ON-BOARD & MANUAL SAMPLE DILUTIONS AS WELL AS UNDILUTED SAMPLES WERE PERFORMED USING SAMPLES WITH TOBRA CONCENTRATIONS WITHIN THE VITROS TOBRA MEASURING RANGE. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATING A SYSTEMIC ISSUE WITH VITROS TOBRA LOT 1513-07-9417. THE INVESTIGATION FOR THE CAUSE OF THE HIGHER THAN EXPECTED TOBRA RESULTS WHEN USING ON-BOARD DILUTIONS VERSUS MANUAL DILUTIONS AT THIS SITE IS ONGOING. EMAIL ADDRESS FOR CONTACT OFFICE IN FIELD ABOVE IS (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS TOBRA RESULTS WERE OBTAINED FROM MULTIPLE SAMPLES (LINEARITY AND AN UNKNOWN FLUID) PROCESSED USING A VITROS 5,1 FS SYSTEM. LINEARITY FLUID LEVEL 5 RESULT OF 12.58 UG/ML VERSUS THE EXPECTED RESULT OF 9.53 UG/ML. LINEARITY FLUID LEVEL 5 RESULT OF 12.82 UG/ML VERSUS THE EXPECTED RESULT OF 9.57 UG/ML. UNKNOWN FLUID RESULT OF 7.77 UG/ML VERSUS THE EXPECTED RESULT OF 5.65 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 CUSTOMER IS NOT YET USING THE VITROS TOBRA ASSAY TO REPORT PATIENT SAMPLE RESULTS, THEREFORE, NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE 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
    414351 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT IN-VITRO DIAGNOSTICS LDO ORTHO-CLINICAL DIAGNOSTICS 1513-07-9417

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown