BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II ASSAY

    MDR report key: 2990025 · Received March 5, 2013

    Report

    Report Number
    3008344661-2013-00014
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED ON (B)(6) 2013 THAT THE EVALUATION SUMMARY HAD AN ERROR. IN HOUSE TESTING WAS COMPLETED WITH LOT 19322LF00, WHICH IS FROM THE SAME BULK MATERIAL AND IS CONSIDERED EQUIVALENT AS THE LOT NUMBER IN QUESTION, 19295LF00. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY, LIST NUMBER 02G22, LOT 19295LF00 WAS IDENTIFIED. (IN THE FINAL REPORT THIS STATEMENT DOCUMENTED THE INCORRECT LOT NUMBER).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. SENSITIVITY TESTING PROTOCOLS, USING INHOUSE PANELS, WERE EXECUTED USING LOT 19322LF00; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE BATCH RECORD REVIEW FOUND NO ISSUES. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY, LIST NUMBER 02G22, LOT 19322LF00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE COMPLETE PATIENT ID NUMBER IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02G22 THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS 01L80 AND 04P53. LOW TEST RESULTS; (B)(4): NO CONSEQUENCES OR IMPACT TO PATIENT; (B)(4)- AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT HBSAG QUALITATIVE II ASSAY. THE CUSTOMER INDICATED THAT A MEDICAL STUDENT WAS PRICKED DURING SURGERY AND CAME INTO CONTACT WITH A PATIENT'S BLOOD. A SPECIMEN FROM THE PATIENT WAS TESTED AND GENERATED THE FOLLOWING RESULTS ((B)(6)). ADDITIONAL RESULT DATA WAS PROVIDED: (B)(6). TESTED UNDER A DIFFERENT ID NUMBER: (B)(6), TESTED (B)(6) 2013. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93036 ARCHITECT HBSAG QUALITATIVE II ASSAY KSJ ABBOTT IRELAND 19295LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-01, SN (B)(4)| LN 03M74-01, SN (B)(4)| LN 03M74-01, SN (B)(4)| ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER