BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 22147254 · Received June 4, 2025

    Report

    Report Number
    3002809144-2025-00179
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 19, 2025
    Report Date
    June 26, 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

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05, AND 510K/PMA/BLA OF P050042. SECTION A1 PATIENT INFORMATION: NO PATIENT INFORMATION AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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 LOT 71568BE01. 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. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT LOT 71568BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INCONSISTENT ALINITY I ANTI-HCV RESULTS ON A DIALYSIS PATIENT. (B)(6) 2025 ALINITY I ANTI-HCV REACTIVE 1.48 S/CO, BUT ROCHE METHOD NEGATIVE 0.04 COI. ROCHE RESULT WAS REPORTED OUT OF THE LAB. (B)(6) 2025 ALINITY I ANTI-HCV NONREACTIVE 0.87 S/CO, REPORTED OUT OF LAB. THE PATIENT¿S HISTORICAL ABBOTT RESULTS WERE POSITIVE: (B)(6) 2024 OF 1.7 S/CO AND (B)(6) 2025 OF 1.6 S/CO. THE CUSTOMER DOES NOT KNOW WHETHER THE PATIENT SHOULD BE NEGATIVE OR POSITIVE FOR ANTI-HCV. NO ADDITIONAL PATIENT INFORMATION CAN BE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INCONSISTENT ALINITY I ANTI-HCV RESULTS ON A DIALYSIS PATIENT. ON (B)(6) 2025 ALINITY I ANTI-HCV REACTIVE 1.48 S/CO, BUT ROCHE METHOD NEGATIVE 0.04 COI. ROCHE RESULT WAS REPORTED OUT OF THE LAB. ON (B)(6) 2025 ALINITY I ANTI-HCV NONREACTIVE 0.87 S/CO, REPORTED OUT OF LAB. THE PATIENT¿S HISTORICAL ABBOTT RESULTS WERE POSITIVE: (B)(6) 2024 OF 1.7 S/CO AND (B)(6) 2025 OF 1.6 S/CO. THE CUSTOMER DOES NOT KNOW WHETHER THE PATIENT SHOULD BE NEGATIVE OR POSITIVE FOR ANTI-HCV. NO ADDITIONAL PATIENT INFORMATION CAN BE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644757 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)