BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 2840317 · Received November 20, 2012

    Report

    Report Number
    3008344661-2012-00068
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL SENSITIVITY TESTING WAS PERFORMED FOR THE LIKELY CAUSE LOT 15623LF00. THE REAGENT LOT WAS ASSESSED BY TESTING ONE REPLICATE OF EACH LEVEL OF TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (PHM927 AND PHM929). REAGENT LOT 15623LF00 DETECTED THE SAME FIRST REACTIVE BLEED OF THE SEROCONVERSION PANEL AS HISTORICAL DATA AND THE PANEL MANUFACTURER'S DATA. FROM THIS ASSESSMENT IT IS CONCLUDED THAT THE ARCHITECT HBSAG QUALITATIVE II REAGENT LOT 15623LF00 IS PERFORMING ACCEPTABLY WITH REGARD TO CLINICAL SENSITIVITY. A CUSTOMER RETURN PATIENT SAMPLE WAS TESTED PER THE ASSAY PACKAGE INSERT PROCEDURE WITH THE ARCHITECT HBSAG QUALITATIVE II ASSAY. TESTING WAS CARRIED OUT WITH LOT 16462LF00 BECAUSE LOT 15623LF00 HAD EXPIRED UPON ARRIVAL OF THE PATIENT SAMPLE. A (B)(6) ARCHITECT HBSAG QUALITATIVE II RESULT WAS GENERATED FOR THE SAMPLE. ADDITIONAL REFERENCE TESTING WAS PERFORMED WITH A REPRESENTATIVE LOT OF THE ARCHITECT HBSAG QUALITATIVE (LIST 1P97) ASSAY AND A (B)(6) RESULT WAS OBTAINED. THUS THE OBSERVATION OF A (B)(6) RESULT USING THE ARCHITECT HBSAG QUALITATIVE II ASSAY WAS REPLICATED. ALTHOUGH THE IN-HOUSE PATIENT SAMPLE RETURN TEST RESULTS CONFIRM THE CUSTOMER ISSUE, SEROCONVERSION PANEL TESTING SHOWS THAT THE PRODUCT IS PERFORMING ACCEPTABLY, INDICATING A SAMPLE SPECIFIC CAUSE IN RELATION TO THE ARCHITECT HBSAG SCREENING ASSAYS. GIVEN THE ABOVE RESULTS AND THE OTHER (B)(6) MARKER RESULTS GENERATED AT THE CUSTOMER LABORATORY IT IS CONCLUDED THAT THIS SAMPLE'S (B)(6) RESULT WAS (B)(6). A REVIEW OF THE MANUFACTURING AND TESTING RECORDS FOR LOT 15623LF00 WAS PERFORMED. THIS REVIEW DID NOT REVEAL ANY EVENTS OR ISSUES THAT MAY HAVE IMPACTED THE PERFORMANCE OF THE ABOVE LOT NUMBER IN RELATION TO THIS COMPLAINT ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT HBSAG QUALITATIVE II REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A DEFICIENCY/MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2G22 THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE U.S., LIST NUMBERS 1L80 AND 4P53. 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 INDICATED THAT A (B)(6) ARCHITECT HBSAG QUALITATIVE II RESULT OF (B)(6) WAS GENERATED ON A PATIENT THAT WAS (B)(6) WITH (B)(6). THE CUSTOMER STATED THE ISSUE WAS DUE TO MUTANT 127L. OTHER MARKER RESULTS WERE: (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG QUALITATIVE II KSJ ABBOTT IRELAND 15623LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| ARCHITECT I2000 ANALYZER 3M74-01| SN (B)(4)| ARCHITECT I2000 ANALYZER 3M74-01