BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 6375656 · Received March 3, 2017

    Report

    Report Number
    3008344661-2017-00015
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    January 1, 2017
    Report Date
    April 21, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE ARCHITECT (B)(6) ASSAY IS UNKNOWN. THEREFORE, SEARCHES FOR OTHER SIMILAR REAGENT LOT SPECIFIC INCIDENTS OF THIS NATURE AS WELL AS NON CONFORMANCES, DEVIATIONS AND SPECIFICITY TESTING COULD NOT BE PERFORMED. A REVIEW OF THE TRACKING AND TRENDING REPORTS CONCLUDED THAT THERE ARE NO ADVERSE OR NON-STATISTICAL TRENDS IDENTIFIED FOR THE REPORTED ISSUE. BASED ON THIS INFORMATION, THE PRODUCT IS PERFORMING AS INTENDED AND NO PRODUCT ISSUES WERE IDENTIFIED. THERE IS NO INDICATION OF AN INCORRECT USE OF THE ASSAY. THE ARCHITECT (B)(6) ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT DOCUMENTED ISSUE. BASED ON THE INFORMATION OBTAINED THROUGH THIS EVALUATION AND THE INFORMATION DOCUMENTED IN THE LITERATURE, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A PRODUCT MALFUNCTION OCCURRED. THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. IT WAS CONFIRMED THAT THE INTRAVENOUS (B)(6) INFUSED INTO THE PATIENT DID CONTAIN (B)(6). AS (B)(6) (B)(6) TYPICALLY HAS A HALF-LIFE OF 18 TO 23 DAYS (WITH SUBCLASS VARIATION), PATIENTS MAY DEVELOP TRANSIENT DETECTABLE (B)(6) TO A RANGE OF INFECTIOUS AGENTS, INCLUDING (B)(6). NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 07C18, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L82. JOURNAL CITATION: BENWELL, NICOLA, ET.AL. (B)(6) CORE AND SURFACE ANTIBODIES DUE TO INTRAVENOUS IMMUNOGLOBULIN. INTERNAL MEDICINE JOURNAL, JANUARY 2017 VOL. 47(1); 119-120. DOI: 10.1111/IMJ.13314.

    Description of Event or Problem · 1

    A (B)(6) MALE DIAGNOSED WITH CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY HAD BEEN RECEIVING INTRAVENOUS IMMUNOGLOBULIN (IVIG) THERAPY AND HIGH DOSE ORAL PREDNISOLONE WHEN DIAGNOSED IN (B)(6) 2014. IN (B)(6) 2015, 1000 MG MONTHLY CYCLOPHOSPHAMIDE WAS STARTED. PER GUIDELINES IN PLACE, THIS PATIENT WAS CONSIDERED TO BE AT MODERATE RISK OF (B)(6) IF PRESENT. BLOOD SAMPLES TAKEN FROM THIS PATIENT WERE SCREENED ON THE ARCHITECT I1000SR ANALYZER BETWEEN (B)(6) 2015 WHILE RECEIVING IVIG INFUSION THERAPY WITH TWO SEPARATE BATCHES OF A COMMERCIALLY AVAILABLE PRODUCT (BATCH A AND BATCH B). THE CUSTOMER SUSPECTS THAT (B)(6) WAS TRANSFUSED FROM THE IVIG THERAPY AS THE PATIENT TESTED NOT PROTECTED (B)(6) IN 2009, HAD NO HISTORY OF VACCINATION AND HAD A TITER REDUCTION FOLLOWING IVIG INFUSION. ARCHITECT ANTI-HBS RESULTS RANGED FROM (B)(6) THROUGH (B)(6) 2015. THE RESULTS FROM THE ARCHITECT ANTI-HBS ASSAY DID NOT FIGURE INTO ANY PATIENT TREATMENT DECISIONS. IT WAS CONFIRMED THAT THE IVIG PRODUCTS THAT WERE INFUSED DID CONTAIN (B)(6). THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160594 ARCHITECT ANTI-HBS ANTI-HBS LOM ABBOTT IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other ARCHITECT I1000SR ANALYZER| LN: 01L86-01 SN: UNK