BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 2950866 · Received February 8, 2013

    Report

    Report Number
    3008344661-2013-00007
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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 07C18-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L82. (B)(4).

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. SPECIFICITY TESTING WAS PERFORMED IN HOUSE USING A RETAINED KIT OF REAGENT LOT 18273LF00 AND MET ACCEPTANCE CRITERIA. A REVIEW OF QUALITY RECORDS FOR THE MANUFACTURE AND RELEASE OF THIS REAGENT LOT SHOWS NO ISSUES. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT ANTI-HBS ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEMS OPERATION MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE CURRENT EVALUATION, THE ARCHITECT (B)(6) ASSAY, LIST NUMBER 7C18-25, LOT NUMBER 18273LF00 IS PERFORMING ACCEPTABLY. NO PRODUCT MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS ONE PATIENT SAMPLE GENERATING A (B)(6) ARCHITECT (B)(6) ASSAY RESULT. THE FOLLOWING PATIENT RESULTS WERE PROVIDED: (B)(6). THE PATIENT HAS NOT RECEIVED THE (B)(6) VACCINE. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55016 ARCHITECT ANTI-HBS LOM ABBOTT IRELAND 18273LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4)| ARCHITECT I1000SR ANALYZER LN: 01L86-01| ARCHITECT I1000SR ANALYZER LN: 01L86-01| SN: (B)(4)