BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 20785276 · Received November 26, 2024

    Report

    Report Number
    3002809144-2024-00334
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740169206
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    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

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. 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 SEARCH FOR SIMILAR COMPLAINTS FOR LOT 63247BE00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE. THE TICKET TRENDING REVIEW DID NOT IDENTIFY ANY RELATED TREND REGARDING COMMONALITIES FOR LOT NUMBER 63247BE00 AND ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 63247BE00. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT 63247BE00 WAS PERFORMED. ALL CONTROLS MET SPECIFICATIONS AND NO FALSE NON- REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. ADDITIONALLY, TESTING INCLUDED ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO HISTORICAL ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX, SINCE ARCHITECT ANTI-HCV AND ALINITY I ANTI-HCV ASSAYS ARE EQUIVALENT. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HCV REAGENT LOT NUMBER 63247BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6)2024, SID (B)(6): INITIAL RESULT (B)(6) = 0.87 S/CO, REPEAT ON NEW REAGENT (B)(6). DURING LOT-TO-LOT COMPARISON STUDY = 1.09 S/CO, REPEAT ON NEW LOT = 1.19 S/CO, REPEAT ON ORIGINAL LOT = 1.12 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6): INITIAL RESULT (63247BE00) = 0.87 S/CO, REPEAT ON NEW REAGENT (64331BE00) DURING LOT-TO-LOT COMPARISON STUDY = 1.09 S/CO, REPEAT ON NEW LOT = 1.19 S/CO, REPEAT ON ORIGINAL LOT = 1.12 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598247 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 63247BE00 00380740169206

    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).