BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS RE CONTROLS

    MDR report key: 20080639 · Received August 27, 2024

    Report

    Report Number
    3007111389-2024-00164
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJY
    UDI-DI
    10758750008322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT A VITROS OPERATOR EXPERIENCED LEFT EYE PAIN CAUSED BY GLASS DUST THAT MAY HAVE ENTERED HIS LEFT EYE, PRODUCED BY A SHATTERED GLASS BOTTLE OF VITROS REPRODUCTIVE ENDOCRINE (RE) CONTROLS. THE RE CONTROL VIAL BROKE WHEN THE OPERATOR TAPPED THE VIAL ON THE BENCHTOP TO DISLODGE LYOPHILATE. THE GLASS VIAL SHATTERED AND THE BOTTOM OF THE VIAL TURNED TO A GLASS DUST, NOT SHARDS, WHICH THE OPERATOR SUSPECTED GOT INTO HIS EYE. THE OPERATOR WAS WEARING A LAB COAT, NITRILE GLOVES, AND SAFETY GLASSES. THE VITROS RE CONTROL IFU DOES NOT INDICATE TO DISLODGE THE LYOPHILATE BY GENTLY TAPPING THE VIAL ON A HARD SURFACE. THEREFORE, USER ERROR LIKELY CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) WAS CONTACTED TO REPORT A VITROS OPERATOR EXPERIENCED LEFT EYE PAIN POTENTIALLY CAUSED BY GLASS DUST THAT MAY HAVE ENTERED HIS LEFT EYE, PRODUCED BY A SHATTERED GLASS BOTTLE OF VITROS REPRODUCTIVE ENDOCRINE (RE) CONTROLS. THE OPERATOR IMMEDIATELY RINSED HIS EYE WITH WATER AND THEN SOUGHT MEDICAL TREATMENT. THE EYE DOCTOR WAS ABLE TO VERIFY THAT THE EYE, THOUGH INFLAMED, DID NOT CONTAIN ANY FOREIGN MATERIAL AND DID NOT LOOKED DAMAGED FROM SCRATCHING. PER MEDICAL CONSULTATION FROM MEDICAL SAFETY OFFICER (B)(6) DATED (B)(6) 2024: PER THE SDS, THE RE CONTROL CONTAINS HUMAN PLASMA, HUMAN CORD SERUM/PLASMA, AND KATHON (A CHEMICAL MIXTURE). DUE TO THE PRESENCE OF HUMAN BLOOD AND BLOOD PRODUCTS, THERE EXISTS THE RISK OF TRANSMISSION OF BLOOD-BORNE PATHOGENS UPON EXPOSURE TO THE BODY MUCOSA. DONORS AND DONATION BLOOD FOR ORTHO REAGENTS TESTED NEGATIVE PER CURRENT FDA-REQUIRED TESTS; THEREFORE, THE CHANCE OF BEING TRANSMITTED WITH THE COMMON BLOOD-BORNE PATHOGENS IS LOW. HOWEVER, NO TEST CAN GUARANTEE 100% DETECTION. SO, FOR PRECAUTION, THIS CASE IS CLASSIFIED AS SERIOUS INJURY. THE REAGENT IS ALSO LISTED AS AN EYE IRRITANT, WHICH THE OPERATOR MAY HAVE EXPERIENCED. THE NECESSARY FIRST AID MEASURE INCLUDES IMMEDIATE RINSE WITH WATER, WHICH WAS DONE IN THIS CASE. MEDICAL CARE WAS SUPPORTIVE, WITH NO ACTIVE MANAGEMENT FOR INFLAMMATION. BASED ON THE DESCRIPTION, IT APPEARS THAT THE OPERATOR MAY HAVE SUFFERED A MILD ALLERGIC REACTION. THEREFORE, SERIOUS LONG-TERM INJURY DUE TO THE ALLERGIC REACTION IS NOT ANTICIPATED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 607141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520449 VITROS IMMUNODIAGNOSTIC PRODUCTS RE CONTROLS IN-VITRO DIAGNOSTICS JJY ORTHO-CLINICAL DIAGNOSTICS, INC. 0890 10758750008322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown