BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 2032022 · Received March 28, 2011

    Report

    Report Number
    3002809144-2011-00112
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ABBOTT
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT ((B)(6), LIST 4J27) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US ((B)(6), LIST 2P36). NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. REVIEW OF IN-HOUSE STABILITY DATA OF REAGENT LOT NUMBER 92434HN00, WHICH CONTAINS IDENTICAL BULK REAGENTS AS LOT NUMBER 92447HN00, SHOWED THAT ALL CONTROL VALUES MET SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. NO ATYPICAL INCREASED VALUES OR FALSE REACTIVE RESULTS WERE OBTAINED FOR THE NEGATIVE CONTROL. STABILITY TESTING OF LOT NUMBER 92434HN00 WAS PERFORMED BY TESTING (B)(4) REPLICATES OF THE CALIBRATOR, THE NEGATIVE CONTROL AND EACH OF THE POSITIVE CONTROLS OVER A RANGE OF THREE TEST POINTS. COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBERS WERE REVIEWED AND A REVIEW OF (B)(4) TESTING FOR FINAL RELEASE WAS PERFORMED AND DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. BASED ON THE EVALUATION, IT WAS DETERMINED THAT THE (B)(6) REAGENT, LIST NUMBER 4J27-36, LOT NUMBER 92447HN00 IS PERFORMING ACCEPTABLY. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE (B)(6) REAGENT PACKAGE INSERT STATES THAT INITIALLY REACTIVE RESULTS SHOULD BE RETESTED IN DUPLICATE AND THAT A REPEATEDLY REACTIVE SPECIMEN SHOULD BE INVESTIGATED FURTHER WITH SENSITIVE, SUPPLEMENTAL HIV-SPECIFIC TESTS, SUCH AS (B)(6), ANTIGEN TESTS, AND (B)(6) TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A (B)(6) MALE CAME TO THE HOSPITAL AS HE WAS ILL (ILLNESS OR SYMPTOMS WERE NOT AVAILABLE DUE TO PATIENT CONFIDENTIALITY). (B)(6) TESTING WAS PERFORMED AND WAS POSITIVE USING THE ARCHITECT (B)(6) ASSAY, BUT NEGATIVE USING THE DAINASCREEN METHOD. AN (B)(6) INFECTION WAS NOT SUSPECTED FOR THIS PATIENT. A LIVER FUNCTION TEST SHOWED AN ABNORMAL RESULT (NO DETAILS PROVIDED). (B)(6) MARKERS WERE NEGATIVE. THE CUSTOMER WAS INFORMED THAT (B)(6) CONFIRMATORY TESTING SHOULD BE DONE. WHEN THE CUSTOMER DISCUSSED WITH THE DOCTOR THE NEED TO DO CONFIRMATORY TESTING, THE DOCTOR INFORMED THE CUSTOMER THAT THE PATIENT HAD DIED. DATE AND CAUSE OF DEATH WERE NOT PROVIDED DUE TO PATIENT CONFIDENTIALITY. THE CUSTOMER SUSPECTED THAT THE ARCHITECT RESULTS WERE FALSELY POSITIVE DUE TO A NONSPECIFIC REACTION (SERUM RESULT WAS 300 S/CO AND PLASMA RESULT WAS 200 S/CO). THE PATIENT DEATH OCCURRED BEFORE THE DOCTOR RECEIVED THE POSITIVE ARCHITECT (B)(6) RESULT. THE CUSTOMER CONFIRMED THAT THERE WAS NO TREATMENT GIVEN BASED ON THE POSITIVE RESULT AND THAT THE ARCHITECT (B)(6) ASSAY DID NOT CONTRIBUTE TO THE PATIENT DEATH. BASED ON THE INFORMATION PROVIDED, IT IS NOT TEMPORALLY POSSIBLE FOR THE ABBOTT PRODUCT TO HAVE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT AS THE PATIENT HAD EXPIRED BEFORE THE RESULTS WERE REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HIV AG/AB COMBO FOR THE DETECTION OF HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT 92447HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR ARCHITECT I2000SR LIST 3M74-01, (B)(4)