BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 22082902 · Received May 25, 2025

    Report

    Report Number
    3002809144-2025-00166
    Event Type
    Malfunction
    Date Received
    May 25, 2025
    Date of Event
    May 16, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162665
    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

    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 08P06-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05, WITH 510K/PMA/BLA NUMBER P050042.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT. 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 ALINITY I ANTI-HCV ASSAY AND COMPLAINT LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL CONTROLS MET SPECIFICATIONS AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT PERFORMS AS EXPECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT LOT 71568BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I ANTI-HCV. INITIAL TEST RESULT WAS 0.11 S/CO (NON-REACTIVE). RE-TEST RESULT WAS 1.05 S/CO (REACTIVE). THE SAMPLE WAS REPEATED FURTHER, AND RESULTS WERE 0.93 S/CO (NON-REACTIVE) AND 0.93 S/CO (NON-REACTIVE). CUSTOMER COMMUNICATED THAT THE INITIAL TEST RESULT WAS REPORTED TO THE CLINIC. AND THAT THEY BELIEVE THAT REACTIVE RESULTS ARE THE CORRECT RESULT. THE PATIENT IS A HEMODIALYSIS PATIENT UNDERGOING ANTICOAGULATION THERAPY. THE PATIENT HAS A HISTORY OF POSITIVE ANTI-HCV TEST. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I ANTI-HCV. INITIAL TEST RESULT WAS 0.11 S/CO (NON-REACTIVE). RE-TEST RESULT WAS 1.05 S/CO (REACTIVE). THE SAMPLE WAS REPEATED FURTHER, AND RESULTS WERE 0.93 S/CO (NON-REACTIVE) AND 0.93 S/CO (NON-REACTIVE). CUSTOMER COMMUNICATED THAT THE INITIAL TEST RESULT WAS REPORTED TO THE CLINIC. AND THAT THEY BELIEVE THAT REACTIVE RESULTS ARE THE CORRECT RESULT. THE PATIENT IS A HEMODIALYSIS PATIENT UNDERGOING ANTICOAGULATION THERAPY. THE PATIENT HAS A HISTORY OF POSITIVE ANTI-HCV TEST. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014015 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 71568BE01 00380740162665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)