BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK

    MDR report key: 16349311 · Received February 10, 2023

    Report

    Report Number
    3007111389-2023-00015
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 14, 2023
    Report Date
    February 9, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    DHA
    UDI-DI
    10758750002320
    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 LOWER THAN EXPECTED VITROS TOTAL B-HCG II (BHCG) RESULTS WERE OBTAINED FROM VITROS REPRODUCTIVE ENDOCRINOLOGY QUALITY CONTROLS USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL BHCG II REAGENT LOT 3580 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A POSSIBLE CAUSE FOR THE INITIAL LOWER THAN EXPECTED VITROS BHCG QC FLUID RESULTS IS A SUBOPTIMAL CALIBRATION. THE PARAMETERS FOR THE CALIBRATION USED WHEN OBTAINING THE INITIAL LOWER THAN EXPECTED RESULTS WERE ATYPICAL WHEN COMPARED TO DATABASE VALUES AND THE PREVIOUS CALIBRATION. THE CAUSE OF THE SUBOPTIMAL CALIBRATION IS UNKNOWN. BASED ON HISTORICAL QUALITY CONTROL RESULTS FROM NON-VITROS BIORAD QC FLUIDS, A VITROS BHCG LOT 3580 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, AS VITROS RE RESULTS RETURNED TO EXPECTATIONS USING AN ALTERNATE LOT OF VITROS BHCG REAGENT, AN ISSUE RELATED TO VITROS BHCG LOT 3580 CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. AN INSTRUMENT RELATED ISSUE IS NOT LIKELY A CONTRIBUTOR OF THE EVENT AS VITROS TSH WITHIN RUN PRECISION RESULTS WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. ADDITIONALLY, THE USE OF AN ALTERNATE VITROS BHCG REAGENT RESOLVED THE ISSUE WITHOUT ANY KNOWN ACTIONS BEING PERFORMED ON THE VITROS ECI SYSTEM. A VITROS RE LOT 0830 RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT AS THE ISSUE WAS RESOLVED USING AN ALTERNATE LOT OF RE CONTROLS ALONG WITH AN ALTERNATE LOT OF VITROS BHCG REAGENT. IN ADDITION, AS THE RESULTS FOR EACH LEVEL OF VITROS RE CONTROLS LOT 0830 WERE SIGNIFICANTLY LOWER THAN THE PI MEANS, AN ISSUE RELATED TO SAMPLE HANDLING CANNOT BE RULED OUT AS A POSSIBLE CAUSE OF THE LOWER THAN EXPECTED RESULTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS BHCG REAGENT LOT 3580 OR VITROS RE CONTROLS LOT 0830.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TOTAL B-HCG II (BHCG) RESULTS WERE OBTAINED FROM VITROS REPRODUCTIVE ENDOCRINOLOGY (RE) QUALITY CONTROLS USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL BHCG II REAGENT LOT 3580 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS RE LOT 0830 LEVEL 1 RESULTS OF 3.48, 3.42, 3.44, 3.5, 3.67, 3.61, 3.46, 3.48, 3.56, 3.57, 3.52 AND 3.54 IU/L VS AN EXPECTED RESULT OF 11.06 IU/L 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 VITROS BHCG RESULTS WERE FROM NON-PATIENT FLUIDS. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED. THERE IS 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
    1067115 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK IN-VITRO DIAGNOSTICS DHA ORTHO-CLINICAL DIAGNOSTICS, INC. 6802220 3580 10758750002320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown