BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 21706528 · Received March 27, 2025

    Report

    Report Number
    3002809144-2025-00109
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162580
    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 ALINITY I ANTI-HBC II REAGENT LOT NUMBER 67557BE01 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. A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS TESTED IN A SENSITIVITY SETUP. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO PRODUCT SYSTEMIC ISSUE OR 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 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT ON A 42-YR OLD MALE PATIENT. RESULTS PROVIDED: ANTI-HBC = 1.03 / 0.62 / 0.64 S/CO OTHER RESULTS PROVIDED: HBSAG = >250; ANTI-HBS = 0.67; HBEAG = 21.51; ANTI-HBE = 3.44; HEP B NUCLEIC ACID TEST IS NEGATIVE. PATIENT HISTORY: CHRONIC HEPATITIS B FOR 14 YEARS ON ORAL ENTECAVIR TREATMENT, NORMAL LIVER FUNCTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT ON A 42-YR OLD MALE PATIENT. RESULTS PROVIDED: ANTI-HBC = 1.03 / 0.62 / 0.64 S/CO. OTHER RESULTS PROVIDED: HBSAG = >250; ANTI-HBS = 0.67; HBEAG = 21.51; ANTI-HBE = 3.44; HEP B NUCLEIC ACID TEST IS NEGATIVE. PATIENT HISTORY: CHRONIC HEPATITIS B FOR 14 YEARS ON ORAL ENTECAVIR TREATMENT, NORMAL LIVER FUNCTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659241 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 67557BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)