BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 21963396 · Received May 5, 2025

    Report

    Report Number
    3002809144-2025-00151
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 16, 2025
    Report Date
    June 3, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740112622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A: 58 YEAR OLD MALE PATIENT: SID (B)(6) 84 YEAR OLD FEMALE PATIENT: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L79, WITH 510K/PMA/BLA NUMBER P050042.

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT ANTI-HCV ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69348BE00 AND COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 69348BE00. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF LOT 69348BE00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOTS GENERATE THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO HISTORICAL ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT ANTI-HCV FOR LOT 69348BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: 58 YEAR OLD MALE PATIENT: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.35 S/CO, REPEAT = 2.18 S/CO, HISTORICAL RESULT FROM (B)(6) 2024 = 2.57 S/CO. 84 YEAR OLD FEMALE PATIENT: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.25 S/CO, REPEAT = 1.82 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: 58 YEAR OLD MALE PATIENT: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.35 S/CO, REPEAT = 2.18 S/CO, HISTORICAL RESULT FROM (B)(6) 2024 = 2.57 S/CO. 84-YEAR-OLD FEMALE PATIENT: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 0.25 S/CO, REPEAT = 1.82 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468711 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GMBH 69348BE00 00380740112622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, ISR60316| ARC I2K PROC MOD, 03M74-01, ISR60316