BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV

    MDR report key: 9542038 · Received January 2, 2020

    Report

    Report Number
    3002809144-2020-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    November 13, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NAME UPDATED FROM ABBOTT TO ABBOTT GMBH. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D.2. PRODUCT CODE UPDATED FROM MZO TO QHM. TICKET SEARCHES DETERMINED THAT THERE IS AN ELEVATED COMPLAINT ACTIVITY LOT 94679LI00 AND A NORMAL COMPLAINT ACTIVITY FOR LOT 07518BE00. THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO RELATED ADVERSE TRENDS. REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE PERFORMANCE OF THE COMPLAINT LOTS WAS INVESTIGATED BY COMPLETING A REVIEW IN THE CAPA SYSTEM FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE COMPLAINT LOTS. THIS REVIEW DID NOT REVEAL ANY EVENTS OR ISSUES THAT MAY HAVE IMPACTED THE PERFORMANCE OF THE LOT NUMBER IN RELATION TO THE COMPLAINT ISSUE. TO EVALUATE CLINICAL SENSITIVITY OF THE TWO AFFECTED ALINITY S ANTI-HCV REAGENT LOTS 94679LI00 AND 07518BE00, FOR EACH LOT TWO SENSITIVITY PANELS (ANTI-HCV CORE ONLY PANEL AND ANTI-HCV NS3 ONLY PANEL) WERE TESTED. THE SENSITIVITY PANELS MET SPECIFICATIONS AND THE RESULTS WERE IN THE TYPICAL RANGE AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS WITH BOTH LIKELY CAUSE LOTS. THE SEROCONVERSION PANEL RESULTS OF THE PANELS WERE COMPARED TO HISTORICAL DATA OF ALINITY S ANTI-HCV TEST RESULTS. THE REAGENT LOTS 94679LI00 AND 07518BE00 DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANELS. THE ABBOTT ALINITY S ANTI-HCV ASSAY IS DESIGNED WITH THE HCR43 AND C100 RECOMBINANT ANTIGENS. THESE RECOMBINANT ANTIGENS INCLUDE AMINO ACID SEQUENCES FROM EACH THE CORE, NS3, AND NS4 CODING REGIONS OF THE HCV GENOME. THE ASSOCIATED INNO-LIA IMMUNOBLOT RESULTS THAT WERE PROVIDED SHOWED AN E2 (2+) AND NS4 (1+) SEROLOGICAL PATTERN. THE C100 RECOMBINANT ANTIGEN IN THE ALINITY S ANTI-HCV DESIGN DETECTS NS4 ANTIBODIES, HOWEVER, NS4 ANTIBODIES DEPENDENT ON THE GENOTYPE ARE HIGHLY VARIABLE WHICH CAN IMPACT DETECTABILITY. THE INNO-LIA DESIGN INCLUDES EPITOPES ALLOWING FOR GREATER SENSITIVITY TO THESE HIGHLY VARIABLE REGIONS. THE E2 VIRAL STRUCTURAL PROTEIN IDENTIFIED IN THE IMMUNOBLOT SEROLOGICAL PATTERN IS OUTSIDE OF THE ALINITY S ANTI-HCV IMMUNOASSAY DESIGN. THE TEST RESULTS PROVIDED BY THE CUSTOMER, PROVIDES SUFFICIENT EVIDENCE OF THE TESTING PROFILE OF THIS SAMPLE. FOR THIS REASON, THE RETURN SAMPLE WILL NOT BE PURSUED TO SUPPORT THE COMPLAINT INVESTIGATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 6P04-55, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 6P04-60. PATIENT IDENTIFIER DOES NOT CONTAIN ENOUGH SPACES, THE ENTIRE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSE (B)(6) ALINITY S (B)(6) (0.16, 0.15 S/CO) USING 2 ALINITY I ANALYZERS ON (B)(6) YEAR OLD MALE WITH SID (B)(6) THAT TESTED ARCHITECT I1000SR (B)(6), ROCHE METHOD (B)(6) AND INNOLIA BLOT (B)(6) 2+. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO RACE OR ETHNICITY WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4542 ALINITY S ANTI-HCV ANTI-HCV QHM ABBOTT GMBH 94679LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR ALINITY S LIST 06P16-01| ALINITY S LIST 06P16-01| ALINITY S LIST 06P16-01| SERIAL (B)(6)| SERIAL (B)(6)| SERIAL (B)(6)