BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A BIOCLONE 15X10ML

    MDR report key: 21101093 · Received January 8, 2025

    Report

    Report Number
    2250051-2025-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 2, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    QHR
    UDI-DI
    10758750003020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: CUSTOMER CONFIRMED THAT ALL QUALITY CONTROL TESTING WAS AS EXPECTED ON THE DAY OF TESTING. CUSTOMER CONFIRMED THAT THE REAGENTS WERE STORED AS PER ORTHO SPECIFICATIONS AND VISUAL INSPECTIONS OF THE GEL CARD AND ANTI-SERA REAGENTS PRIOR TO USE WERE ACCEPTABLE. THE CUSTOMER DID NOT PROVIDE GTSC WITH ANY ADDITIONAL DETAIL OF THEIR MANUAL TUBE TESTING. AS PART OF THE INVESTIGATION, A REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR ORTHO ANTI-A BIOCLONE LOT BAA632A, EXPIRY 21JUN2025. NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR THE LOT. NO TREND IDENTIFIED. ((B)(4)) INVESTIGATION OF THE ORIGINAL FALSE NEGATIVE RESULT WITH MTS ABD MONOCLONAL GROUPING CARD LOT 081624053-03 WAS CAPTURED UNDER (B)(4). NO FURTHER INVESTIGATION WAS PERFORMED ON THIS INCIDENT WITH THE ANTI-A BIOCLONE IN MANUAL TUBE METHOD. THE ASSIGNABLE CAUSE IS THE DONOR HAVING AN ABO SUBGROUP OF A. IN MITIGATION OF THIS COMPLAINT, THE INSTRUCTIONS FOR USE FOR BLOOD GROUPING REAGENTS ANTI-A (ANTI-ABO1)(MURINE MONOCLONAL BLEND) LIMITATIONS OF THE PROCEDURE STATES: "SOME SUBGROUPS OF THE A (ABO1) ANTIGEN MAY NOT BE DETECTED BY THESE ANTI-A (ANTI-ABO1) AND ANTI-A,B (ANTI-ABO3) REAGENTS." IN ANY CASE, THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENT TO PERFORM AS INTENDED. NO FURTHER COMPLAINT OF THIS TYPE HAS BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR ONE DONOR UNIT WHEN PERFORMING ABO UNIT CONFIRMATION TYPING UTILIZING ORTHO ANTI-A BIOCLONE LOT BAA632A, EXPIRY 21JUN2025, IN MANUAL TUBE METHOD. COMPLAINANT: (B)(6); SENIOR TECHNICIAN (B)(6); (B)(6) MEDICAL CENTER (B)(6) DATE OF EVENT: 05DEC2024 (REPORTED (B)(6)2024) REAGENT: ORTHO ANTI-A BIOCLONE LOT BAA632A, EXPIRY 21JUN2025, MANUFACTURE 21JUN2023. DONOR INFORMATION: ONE DONOR UNIT LABELED A POSITIVE. UNIT ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY PERFORMED REPEAT ABO FORWARD TESTING ON ONE DONOR UNIT IN MANUAL TUBE METHOD FOLLOWING DISCREPANT RESULTS IN MTS GEL METHOD AND THEY OBTAINED AN ABO FORWARD TYPE OF O POSITIVE WHEN A POSITIVE WAS EXPECTED. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER STATED THEY RETURNED THE UNIT TO THEIR BLOOD SUPPLIER, (B)(4), AND THAT (B)(4) REPORTED THAT THE UNIT RETYPED AS SEROLOGICAL O POSITIVE AND CONCLUDED THE ABORH OF THE UNIT AS AN A SUBGROUP RH POSITIVE. (B)(4) ALSO INDICATED THAT THE UNIT WOULD BE SENT TO THE BLOOD CENTER, CREATIVE TESTING SOLUTIONS (CTS), FOR FURTHER EVALUATION. NO FURTHER DETAILS WERE PROVIDED. THE UNIT WAS NOT USED FOR TRANSFUSION AND WAS RETURNED TO THE BLOOD SUPPLIER. NO BIASED RESULTS WERE REPORTED TO THE CLINICIANS. NO DONOR OR PATIENT WAS HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036464 ANTI-A BIOCLONE 15X10ML BLOOD GROUPING REAGENT QHR ORTHO-CLINICAL DIAGNOSTICS, INC. BAA632A 10758750003020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown