BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 22059045 · Received May 21, 2025

    Report

    Report Number
    3002809144-2025-00162
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740169213
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 8P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P05, WITH 510K/PMA/BLA NUMBER: P050042.

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR THE LIKELY CAUSE REAGENT LOT NUMBER 72335BE00. THE TICKET SEARCH DETERMINED THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. CLINICAL SENSITIVITY OF THE ALINITY I ANTI-HCV ASSAY WAS EVALUATED WITH A RETAINED KIT OF LOT 72335BE00 AND DEMONSTRATED ACCEPTABLE SENSITIVITY SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I PRODUCT REQUIREMENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANTI-HCV ASSAY, LOT 72335BE00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT ON A PATIENT WITH A HISTORY OF A POSITIVE RESULT. ON (B)(6) 2025 SID: (B)(6). THE CUSTOMER PROCESSED THE SAMPLE ON ANOTHER ALINITY AND WAS POSITIVE (1.47 S/CO). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT ON A PATIENT WITH A HISTORY OF A POSITIVE RESULT. (B)(6) 2025 SID (B)(6). THE CUSTOMER PROCESSED THE SAMPLE ON ANOTHER ALINITY AND WAS POSITIVE (1.47 S/CO). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80587 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 72335BE00 00380740169213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, AI04422| ALNTY I PROCESSING MODU, 03R65-01, AI04422