BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 5042966 · Received August 31, 2015

    Report

    Report Number
    3002809144-2015-00060
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. THE REPORTED ISSUE WAS NEVER CALLED INTO ABBOTT BY THE CUSTOMER AS A COMPLAINT. THE INFORMATION WAS OBTAINED DURING A LITERATURE REVIEW AND AN INTERNAL COMPLAINT WAS CREATED BASED ON THIS ARTICLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THIS DATA, THE PRODUCT IS PERFORMING AS INTENDED AND NO PRODUCT ISSUES WERE IDENTIFIED. THE ARCHITECT HIV AG/AB COMBO ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE 6-MINIPOOL NUCLEIC ACID METHODOLOGY AND (B)(6) VIRAL LOAD TESTING RESULTED NON-REACTIVE RESULTS WITH THE AFFECTED DONATION ((B)(6) 2013) INDICATING THAT THE DONOR WAS MOST LIKELY IN THE EARLY SEROCONVERSION OF THE (B)(6) INFECTION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04J27, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02P36. (B)(6). RUJIROJINDAKUL, P. FIRST REPORT OF HUMAN IMMUNODEFICIENCY VIRUS BREAKTHROUGH TRANSMISSION IN THAILAND AFTER MANDATORY 6-MINIPOOL NUCLEIC ACID TESTING. INTERNATIONAL SOCIETY OF BLOOD TRANSFUSION 2015 (109) 226; POSTER 408. VOX SANGUINIS (2015) 109 (SUPPL. 1), 1-379. ISSN/ISBN: 00429007.

    Description of Event or Problem · 1

    AN INTERNAL PERIODIC LITERATURE REVIEW IDENTIFIED AN ADVERSE EVENT INVOLVING THE HIV AG/AB COMBO ASSAY ON AN ARCHITECT ISYSTEMS ANALYZER. THE ARTICLE MENTIONED THAT HIV WAS TRANSMITTED TO THE RECIPIENT OF THE BLOOD UNIT (PACKED RED CELLS). THE DONOR IS A (B)(6) FEMALE WHO IS A REPEAT BLOOD DONOR. SHE TESTED (B)(6) IN (B)(6) 2013 WHEN HER SAMPLE WAS TESTED WITH THE ARCHITECT HIV AG/AB COMBO ASSAY. THIS DONOR WAS LAST TESTED BACK IN (B)(6) 2013 AT HER LAST BLOOD DONATION (NUMBER 17) AND AT THAT TIME TESTED (B)(6) WITH THE ARCHITECT HIV AG/AB COMBO ASSAY AND (B)(6) WITH THE 6-MINIPOOL NUCLEIC ACID METHODOLOGY (6-MP NAT; COBAS TAQSCREEN MPX, S201 SYSTEM, ROCHE). COMPONENTS FROM THE (B)(6) 2013 DONATION WERE USED IN THE TRANSFUSION. THE RECIPIENT RECEIVED PACKED RED BLOOD CELLS AND TESTED (B)(6) IN (B)(6) 2013 (THIS MALE PATIENT'S PREVIOUS (B)(6) STATUS BEFORE THIS TRANSFUSION WAS (B)(6)). THE ARTICLE FURTHER DESCRIBES THE INVESTIGATION OF THE HOMOLOGY OF THE (B)(6) GENOME USING POST-SEROCONVERSION PLASMA FROM THE DONOR AND THE RECIPIENT OF THE PACKED RED BLOOD CELLS. ALSO, A RETAINED SAMPLE FROM THE (B)(6) 2013 DONATION WAS TESTED FOR (B)(6) VIRAL LOAD. THE PHYLOGENETIC ANALYSIS SHOWED 99.8% SIMILARITY BETWEEN THE DONOR AND THE PATIENT. THE (B)(6) VIRAL LOAD IN THE RETAINED DONOR PLASMA FROM THE (B)(6) 2013 DONATION WAS BELOW DETECTION LIMITS OF LESS THAN 20 COPIES/ML. THERE IS NO FURTHER INFORMATION AVAILABLE AND NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575659 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ARCHITECT ISYSTEMS ANALYZER