BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEIX ULTRIO ELITE ASSAY

    MDR report key: 22822234 · Received August 15, 2025

    Report

    Report Number
    2032600-2025-00003
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 15, 2025
    Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Product Code
    QHO
    UDI-DI
    00859882007672
    PMA / PMN Number
    BL125652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 17JUL2025, GRIFOLS CUSTOMER CREATIVE TESTING SOLUTIONS AZ (USE) REPORTED DISCREPANCY BETWEEN UE SCREENING AND DISCRIMINATORY TESTING. TESTING WAS PERFORMED IN (B)(6) 2025 USING MASTER LOT, PROCLEIX ULTRIO ELITE, MN 9051171, LN 708157. MASTER POOL SAMPLE (B)(6) TESTED REACTIVE FOR ULTRIO ELITE. ALL SAMPLES IN THE POOL WERE NONREACTIVE FOR UE IN IDT TESTING. IDT SAMPLE (B)(6) TESTED REACTIVE FOR DHBV DISCRIMINATORY TEST. ALINITY SEROLOGY RESULTS FOR IDT SAMPLE (B)(6) WERE ANTI-HBC (X2) REACTIVE AND HBSAG NONREACTIVE. THE DONATION WAS DEFERRED. SAMPLES WERE NOT AVAILABLE FOR INVESTIGATIONAL TESTING AT GRIFOLS. THE TESTING DATA IS SUMMARIZED BELOW: ULTRIO ELITE SAMPLE ID (B)(6). S/C0 7.92 REACTIVE IDT SAMPLE (B)(6) S/C0 0.11 NONREACTIVE. DHBV DT SAMPLE (B)(6) S/C0 14.13 REACTIVE. SEROLOGY: ALINITY (DONE ON (B)(6) 2025) ANTI-HBC 2X REACTIVE HBSAG NONREACTIVE HCV NONREACTIVE HIV NONREACTIVE. NO RELATED QUALITY EVENTS WERE FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. A PREVIOUS EVENTS SEARCH DID NOT INDICATE A TREND FOR HBV SENSITIVITY ISSUES WITH ULTRIO ELITE ML 708157. THE ROOT CAUSE OF THE NONREACTIVE ULTRIO ELITE RESULT IS LIKELY LOW TITER HBV. INTERMITTENT REACTIVITY IS EXPECTED AT CONCENTRATIONS AT OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. THE SEROLOGICAL PROFILE IS CONSISTENT WITH OCCULT HBV INFECTION (OBI), WHICH IS MARKED BY LOW TO UNDETECTABLE LEVELS OF HBV DNA. NO ADDITIONAL INFORMATION IS EXPECTED, AND THIS IS THE FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2660503 PROCLEIX ULTRIO ELITE ASSAY HIV/HCV/HBV DEVICE QHO GRIFOLS DIAGNOSTIC SOLUTIONS INC. 708157 00859882007672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other