BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO HBC ELISA TEST SYSTEM

    MDR report key: 11766136 · Received May 3, 2021

    Report

    Report Number
    2250051-2021-00027
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 3, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) DISCREPANT RESULTS FOR TWO DONOR SAMPLES. THE ROOT CAUSE IS USER ERROR. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. NO PATIENTS WERE HARMED. (B)(4)

    Description of Event or Problem · 0

    REPORT 2 OF 2 ORTHO ACCOUNT MANAGER REPORTED FOR CUSTOMER. CUSTOMER DISCOVERED THAT THEY INADVERTENTLY USED (B)(6) CONJUGATE INSTEAD OF INTENDED (B)(6) SPECIMEN DILUENT WHEN TESTING 6 HBC PLATES. COMPLAINANT: (B)(6) OCCUPATION: LAB SUPERVISOR COMPLAINT REPORTER: (B)(6) OCCUPATION: ORTHO ACCOUNT MANAGER DATE OF EVENT(S): (B)(6) 2021. REPORTED TO ACCOUNT MANAGER ON: 12APR2021 REPORTED TO ORTHO CARE ON: 14APR2021 (LATENOTE) SOFTWARE VERSION: 4.3 REAGENTS: ORTHO (B)(6) ELISA 2400T (933275) DONOR SAMPLES TESTED THE CUSTOMER REPORTED THAT ON (B)(6) 2021, 6 (B)(6) PLATES WERE TESTED WHICH GAVE VALID RESULTS BASED ON INTERNAL CONTROLS. TSC NOTED THAT THE POSITIVE CONTROLS TO EACH PLATE APPEARED HIGHER THAN NORMAL BUT STILL VALID. THE CUSTOMER REPORTED THAT THE PLATES WERE PROCESSED ON THE SAME BATCH CONSECUTIVELY ON (B)(6) 2021 ON VIP. ACCOUNT MANGER REPORTS AT THE COMPLETION OF PIPETTING, THE USER REMOVED THE SAMPLE DILUENT REAGENT RACK AND NOTED THAT THE (B)(6) CONJUGATE WAS USED INSTEAD OF THE CORRECT (B)(6) SPECIMEN DILUENT. THE PLATES COMPLETED PROCESSING ON THE OSP AND WERE FOUND ALL TO BE VALID. CUSTOMER REQUESTING FURTHER INVESTIGATION AS TO WHY THESE PLATES DID NOT FAIL. CUSTOMER INVALIDATED ALL 6 PLATES AND RETESTED USING THE CORRECT REAGENTS AS PER IFU. TSC FOLLOWED UP WITH ACCOUNT MANAGER ON 28APR2021 REQUESTING REPEAT TESTING RESULTS TO CONFIRM IF ANY DISCREPANCIES WERE NOTED. TWO SAMPLES THAT INITIALLY TESTED AS (B)(6) WITH (B)(4), NOW TEST AS (B)(6) WITH (B)(4) USING THE CORRECT DILUENTS: (B)(6). THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED. THE CUSTOMER REPORTED THAT NO PATIENTS WERE HARMED AS A CONSEQUENCE OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663165 ORTHO HBC ELISA TEST SYSTEM HEPATITIS B CORE ANTIBODY LOM ORTHO CLINICAL DIAGNOSTICS CHK610

    Patients

    Seq Age Sex Outcome Treatment
    1