BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 2019223 · Received March 15, 2011

    Report

    Report Number
    2623532-2011-00008
    Event Type
    Death
    Date Received
    March 15, 2011
    Date of Event
    March 17, 2010
    Report Date
    February 17, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION; FALSE NEGATIVE RESULT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8L44 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L22. THE ARCHITECT (B)(6) II REAGENT 8L44-35 LOT 80140HN00 WAS EXPIRED SINCE (B)(6) 2010. THEREFORE A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS FOR LOT 80140HN00 WAS PERFORMED. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. MASTER LOT RELEASE TESTING DATA FOR LOT NUMBERS 80140HN00 AND 83598HN00 WERE REVIEWED AND INDICATED THE MASTER LOTS WERE RELEASED WITHIN MANUFACTURING SPECIFICATIONS. FOR TESTING PURPOSES A RETAINED KIT OF LOT 83598HN00 WAS USED. THE CALIBRATION AND CONTROL VALUES MET SPECIFICATIONS. THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (SEROCONVERTER PANEL, PROFILE DIAGNOSTICS, CODE (B)(4)). THE SEROCONVERSION PANEL RESULTS WERE COMPARED WITH HISTORICAL TEST DATA. THE REAGENT DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES. BASED ON THE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT (B)(6) II REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE OF DISCREPANT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE CAUSE OF DEATH FOR THE PATIENT THAT HAD RECEIVED THE BLOOD TRANSFUSION. THE PATIENT DIED ON (B)(6), 2010 AND THE CAUSE OF DEATH WAS DETERMINED TO BE DUE TO MULTIPLE ORGAN DYSFUNCTION SYNDROME.

    Description of Event or Problem · 1

    A BLOOD DONOR WAS TESTED (B)(6) 2010 (SAMPLE (B)(6)) WITH NEGATIVE RESULTS FOR ARCHITECT (B)(6) AND ARCHITECT (B)(6). THE DONOR WAS TESTED AGAIN ON (B)(6) 2011 (SAMPLE (B)(6)) AND REACTIVE RESULTS WERE GENERATED WITH MUREX (B)(6). A RETROSPECTIVE ANALYSIS WAS PERFORMED. IT WAS DETERMINED THAT THE PATIENT THAT HAD RECEIVED THE UNIT OF BLOOD FROM (B)(6) 2010 HAD DIED, HOWEVER PER THE ACCOUNT THE CAUSE OF DEATH OF THE RECIPIENT WAS NOT DUE TO THE TRANSMISSION OF (B)(6). ADDITIONAL TESTING WAS PERFORMED ON THE 2 SAMPLES. SAMPLE (B)(6) ((B)(6) 2010). AXSYM (B)(6) REACTIVE ((B)(6)), AXSYM (B)(6) REACTIVE 41.4 MIU/ML, AXSYM (B)(6) NON-REACTIVE (B)(6). ARCHITECT (B)(6) NON-REACTIVE (B)(6). SAMPLE (B)(6) ((B)(6) 2011). AXSYM (B)(6) REACTIVE ((B)(6)), AXSYM (B)(6) REACTIVE 41.8 MIU/ML, AXSYM (B)(6) NON-REACTIVE ((B)(6)). ARCHITECT (B)(6) NON-REACTIVE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HBC II IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPATITIS B CORE ANTIBODIES LOM ABBOTT DIAGNOSTICS INT'L, LTD 80140HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ARCHITECT I2000 ANALYZER 3M74-01 (B)(4)| ARCHITECT I2000 ANALYZER 3M74-01 (B)(4)