BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 7395906 · Received April 4, 2018

    Report

    Report Number
    3002809144-2018-00039
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    November 16, 2017
    Report Date
    May 1, 2018
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO RETURNS MADE AVAILABLE FROM THE CUSTOMER SITE. THERE WAS NO INFORMATION IN REGARDS TO ANY TEST RESULTS FROM THE (B)(6) 2017 DONATION THAT GENERATED ANY REACTIVE/POSITIVE RESULTS. A REVIEW OF COMPLAINT TRENDING DATA WAS PERFORMED AND NO RELATED TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION WERE IDENTIFIED. A REVIEW OF NON-CONFORMANCES DID NOT IDENTIFY ANY EVENT, WHICH MAY HAVE IMPACTED THE PERFORMANCE OF THE PRODUCT. CLINICAL SENSITIVITY OF THIS ASSAY WAS EVALUATED BY USING AN IN-HOUSE RETAINED REAGENT KIT OF THE ARCHITECT HIV AG/AB COMBO ASSAY REAGENT, WHICH CONTAINS THE SAME BULK REAGENTS AS LOT 76123LI00. TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS WERE EVALUATED AND COMPARED TO THE EXPECTED RESULTS PROVIDED BY THE PANEL MANUFACTURER. BASED ON THE TESTING RESULTS, THE SENSITIVITY PERFORMANCE OF THE REAGENT CONTINUES TO MEET SPECIFICATIONS FOR THE ASSAY. A REVIEW OF LABELING WAS ALSO CONDUCTED AND THE ARCHITECT HIV AG/AB COMBO ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE BLOOD DONATION FROM (B)(6) 2017 GAVE NON-REACTIVE RESULTS WHEN TESTED WITH BOTH THE ARCHITECT HIV AG/AB COMBO ASSAY AS WELL AS BY NAT TESTING, WHICH DETECTED NO HIV RNA. THIS SUPPORTS THE CONCLUSION THAT THE DONOR WAS IN THE EARLY PHASE OF INFECTION (DIAGNOSTIC WINDOW PERIOD) WHERE LEVELS OF HIV RNA ANTIGEN AND ANTIBODY WERE BELOW THE DETECTION LIMITS FOR BOTH METHODS. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A SYSTEMIC ISSUE OR PRODUCT DEFICIENCY EXISTS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4), WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A (B)(6) ARCHITECT HIV AG/AB COMBO ASSAY RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER. THE FOLLOWING WAS PROVIDED: THE CUSTOMER REPORTS THAT ONE DONOR SAMPLE (SID (B)(6)) WAS TAKEN ON (B)(6) 2017 AND TESTED NONREACTIVE (0.10 S/CO) WITH THE ARCHITECT HIV AG/AB COMBO ASSAY, LIST NUMBER (B)(4), LOT NUMBER 76123LI00 ON AN ARCHITECT I2000SR ANALYZER. THE SAMPLE ALSO TESTED NONREACTIVE BY A NAT METHODOLOGY FOR (B)(6) INFECTION. THIS PARTICULAR DONOR HAS MADE MULTIPLE DONATIONS IN THE PAST. THE BLOOD DONATION WAS THEN RELEASED FOR USE. THE BLOOD FROM THIS DONATION WAS USED IN THE TREATMENT OF A (B)(6)-YEAR-OLD FEMALE LEUKEMIA PATIENT. APPROXIMATELY ONE MONTH LATER, THE SAME DONOR WAS TESTED WITH A RAPID HIV TEST METHOD, WHICH GENERATED A REACTIVE RESULT. THIS WAS LATER VERIFIED BY TESTING THE SAMPLE ON AN ARCHITECT I2000SR ANALYZER, WHICH GENERATED A REACTIVE RESULT OF (B)(6) S/CO (SID (B)(6)) AND BY NAT TESTING ((B)(6)UNITS). IN (B)(6)2018, THE CUSTOMER VERIFIED THROUGH FURTHER TESTING THAT THE (B)(6) 2017 DONATION WAS WITHIN THE IMMUNOLOGICAL WINDOW OF VIRAL INFECTION (SEROCONVERSION). A SAMPLE FROM THE (B)(6) 2017 DONATION WAS RETESTED ON (B)(6) 2017 AND TESTED NON-REACTIVE AT (B)(6) S/CO. THE (B)(6)-YEAR-OLD FEMALE RECIPIENT OF THE DONOR SAMPLE HAS SINCE TESTED REACTIVE FOR (B)(6) THROUGH NAT TESTING. THERE IS NO FURTHER INFORMATION PROVIDED DUE TO PRIVACY ISSUES OTHER THAN THE (B)(6)-YEAR-OLD FEMALE PATIENT IS RECEIVING MEDICAL CARE AND BEING MONITORED BY HEALTH CARE PROFESSIONALS. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240670 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES, MZF ABBOTT GERMANY 76123LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Disability ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN: 03M74-02 SN: (B)(4)| LN: 03M74-02 SN: (B)(4)