BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV REAGENT KIT

    MDR report key: 21617264 · Received March 17, 2025

    Report

    Report Number
    3002809144-2025-00091
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 25, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162337
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE LOT 68195BE01 IDENTIFIED NORMAL COMPLAINT ACTIVITY. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. AS PART OF THE COMPLAINT OVERALL INVESTIGATION, AN EVALUATION OF LOT 68195BE01 CLINICAL SENSITIVITY WAS PERFORMED WHICH DEMONSTRATED ACCEPTABLE SENSITIVITY PER SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ARCHITECT ANTI-HCV PRODUCT REQUIREMENT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: PT 1 ABBOTT = 0.08 S/CO; ROCHE = 2.33 S/CO (REACTIVE), PT 2 ABBOTT = 0.57 S/CO; ROCHE = 4.09 S/CO (REACTIVE), NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: PT 1 ABBOTT = 0.08 S/CO; ROCHE = 2.33 S/CO (REACTIVE), PT 2 ABBOTT = 0.57 S/CO; ROCHE = 4.09 S/CO (REACTIVE), NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16353 ARCHITECT ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 68195BE01 00380740162337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)