BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV REAGENT KIT

    MDR report key: 18525436 · Received January 17, 2024

    Report

    Report Number
    3002809144-2024-00012
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 7, 2024
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    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, ARCHITECT ANTI-HCV, LIST NUMBER 06C37-74, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L79. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION FROM THE ARTICLE ¿A NEW DOUBLE-ANTIGEN SANDWICH TEST BASED ON THE LIGHT-INITIATED CHEMILUMINESCENT ASSAY FOR DETECTING ANTI-HEPATITIS C VIRUS ANTIBODIES WITH HIGH SENSITIVITY AND SPECIFICITY¿, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED IN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT COULD NOT BE PERFORMED AS THE LIKELY CAUSE LOT IS UNKNOWN. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LIST NUMBER AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT ANTI-HCV REAGENT, LOT NUMBER UNKNOWN.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY LI H, YANG S, CAO D, WANG Q, ZHANG S, ZHOU Y, LIU D, YANG R, CUI L AND ZHU Z (2023), ¿A NEW DOUBLE-ANTIGEN SANDWICH TEST BASED ON THE LIGHT-INITIATED CHEMILUMINESCENT ASSAY FOR DETECTING ANTI-HEPATITIS C VIRUS ANTIBODIES WITH HIGH SENSITIVITY AND SPECIFICITY¿, FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY 13:1222778, DOCUMENTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR 6 PATIENT SAMPLES. THE SAMPLES WERE TESTED WITH OTHER METHODS AND THE ANTI-HCV RESULTS WERE CONFIRMED POSITIVE. THE FOLLOWING DATA WAS PROVIDED IN THE ARTICLE: ARCHITECT ANTI-HCV RESULT = 0.27 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 3.07 S/CO (REACTIVE) ROCHE COBAS RESULT = 14.33 S/CO (REACTIVE) RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, NS4) HCV RNA = NEGATIVE ANTI-HCV CONFIRMATORY RESULT = POSITIVE ARCHITECT ANTI-HCV RESULT = 0.17 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 1.70 S/CO (REACTIVE) ROCHE COBAS RESULT = 12.19 S/CO (REACTIVE) RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, HELICASE) HCV RNA = NEGATIVE ANTI-HCV CONFIRMATORY RESULT = POSITIVE ARCHITECT ANTI-HCV RESULT = 0.18 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 1.38 S/CO (REACTIVE) ROCHE COBAS RESULT = 11.23 S/CO (REACTIVE) RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, NS5) HCV RNA = NEGATIVE ANTI-HCV CONFIRMATORY RESULT = POSITIVE ARCHITECT ANTI-HCV RESULT = 0.12 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 1.20 S/CO (REACTIVE) ROCHE COBAS RESULT = 6.42 S/CO (REACTIVE) RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3) HCV RNA = NEGATIVE ANTI-HCV CONFIRMATORY RESULT = POSITIVE ARCHITECT ANTI-HCV RESULT = 0.94 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 54.73 S/CO (REACTIVE) ROCHE COBAS RESULT = 59.66 S/CO (REACTIVE) RIBA 3.0 RESULT = INDETERMINATE (BANDS ON RIBA = NS3, NS4) HCV RNA = NEGATIVE ANTI-HCV CONFIRMATORY RESULT = POSITIVE ARCHITECT ANTI-HCV RESULT = 0.05 S/CO (NONREACTIVE) LICA 500 SYSTEM RESULT = 12.11 S/CO (REACTIVE) ROCHE COBAS RESULT = 26.17 S/CO (REACTIVE) RIBA 3.0 RESULT = INDETERMINATE (BANDS ON RIBA = NS3, NS4) HCV RNA = 857 IU/ML ANTI-HCV CONFIRMATORY RESULT = POSITIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY LI H, YANG S, CAO D, WANG Q, ZHANG S, ZHOU Y, LIU D, YANG R, CUI L AND ZHU Z (2023), ¿A NEW DOUBLE-ANTIGEN SANDWICH TEST BASED ON THE LIGHT-INITIATED CHEMILUMINESCENT ASSAY FOR DETECTING ANTI-HEPATITIS C VIRUS ANTIBODIES WITH HIGH SENSITIVITY AND SPECIFICITY¿, FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY 13:1222778, DOCUMENTED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR 6 PATIENT SAMPLES. THE SAMPLES WERE TESTED WITH OTHER METHODS AND THE ANTI-HCV RESULTS WERE CONFIRMED POSITIVE. THE FOLLOWING DATA WAS PROVIDED IN THE ARTICLE: ARCHITECT ANTI-HCV RESULT = 0.27 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 3.07 S/CO (REACTIVE). ROCHE COBAS RESULT = 14.33 S/CO (REACTIVE). RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, NS4). HCV RNA = NEGATIVE. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. ARCHITECT ANTI-HCV RESULT = 0.17 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 1.70 S/CO (REACTIVE). ROCHE COBAS RESULT = 12.19 S/CO (REACTIVE). RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, HELICASE). HCV RNA = NEGATIVE. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. ARCHITECT ANTI-HCV RESULT = 0.18 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 1.38 S/CO (REACTIVE). ROCHE COBAS RESULT = 11.23 S/CO (REACTIVE). RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3, NS5). HCV RNA = NEGATIVE. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. ARCHITECT ANTI-HCV RESULT = 0.12 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 1.20 S/CO (REACTIVE). ROCHE COBAS RESULT = 6.42 S/CO (REACTIVE). RIBA 3.0 RESULT = POSITIVE (BANDS ON RIBA = CORE1, CORE2, NS3). HCV RNA = NEGATIVE. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. ARCHITECT ANTI-HCV RESULT = 0.94 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 54.73 S/CO (REACTIVE). ROCHE COBAS RESULT = 59.66 S/CO (REACTIVE). RIBA 3.0 RESULT = INDETERMINATE (BANDS ON RIBA = NS3, NS4). HCV RNA = NEGATIVE. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. ARCHITECT ANTI-HCV RESULT = 0.05 S/CO (NONREACTIVE). LICA 500 SYSTEM RESULT = 12.11 S/CO (REACTIVE). ROCHE COBAS RESULT = 26.17 S/CO (REACTIVE). RIBA 3.0 RESULT = INDETERMINATE (BANDS ON RIBA = NS3, NS4). HCV RNA = 857 IU/ML. ANTI-HCV CONFIRMATORY RESULT = POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052271 ARCHITECT ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)