BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG REAGENT

    MDR report key: 2509885 · Received March 29, 2012

    Report

    Report Number
    3008344661-2012-00022
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 9, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUEST FOR THE DISCREPANT PATIENT SAMPLE WAS PERFORMED VIA (B)(4), HOWEVER, THE SAMPLE WAS NOT RECEIVED FOR EVALUATION, THEREFORE, CLINICAL SENSITIVITY TESTING WAS PERFORMED USING COMMERCIALLY AVAILABLE SEROCONVERSION PANELS WHICH DEMONSTRATED ACCEPTABLE PERFORMANCE FOR 6C36-39, LOT 08522LF00. CLINICAL SPECIFICITY TESTING ALSO SHOWED ACCEPTABLE PERFORMANCE AND THERE WAS NO MALFUNCTION OF LIST NUMBER 6C36-39, LOT 08522LF00 PER PACKAGE INSERT INSTRUCTIONS. REVIEW OF COMPLAINT TRENDING DETERMINED NO ATYPICAL COMPLAINT ACTIVITY WAS OBSERVED FOR THIS REAGENT LOT. REAGENT RELEASE TESTING FOR THIS LOT FOR SALE REVEALED ALL VALUES WERE WITHIN SPECIFICATIONS, AND NO ANOMALIES WERE OBSERVED. REVIEW OF THE ARCHITECT HBSAG QUALITATIVE II PACKAGE INSERT DETERMINED THE INSERT CONTAINS ADEQUATE INFORMATION REGARDING HANDLING OF REPEATEDLY (B)(6) SPECIMENS USING A NEUTRALIZING ASSAY (E.G., ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY) BEFORE DISCLOSING (B)(6) STATUS TO THE PATIENT. ADDITIONALLY, THE ARCHITECT HBSAG (LN 6C36-39) PACKAGE INSERT CONTAINS INFORMATION RELATED TO SAMPLE HANDLING ISSUES WHICH MAY IMPACT (B)(6) RESULTS AND IS LIKELY TO BE THE CAUSE OF THE INITIAL DISCREPANT (B)(6) RESULT OBSERVED BY THE CUSTOMER. THE PACKAGE INSERT ALSO STATES WHEN ARCHITECT HBSAG QUALITATIVE II RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE EVALUATION OF THE CUSTOMER ISSUE CONCLUDED REAGENT 6C36-39 LOT 08522LF00 IS PERFORMING ACCEPTABLY. THE PRODUCT EVALUATION DETERMINED NO PRODUCT DEFICIENCY WAS IDENTIFIED AND NO ADDITIONAL ISSUES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED PATIENT SAMPLE SID (B)(6) FOR EVALUATION BY ABBOTT. THE CUSTOMER'S OBSERVATION OF (B)(6) ARCHITECT HBSAG WAS NOT REPRODUCED, AS A (B)(6) RESULT OF (B)(6) WAS GENERATED IN THE EVALUATION TESTING. IT IS LIKELY THE CUSTOMER GENERATED A (B)(6) RESULT FOR SID (B)(6) DUE TO SAMPLE HANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE NEGATIVE ARCHITECT (B)(6) QUANTITATIVE RESULT WAS GENERATED FOR SID (B)(4) AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2012, REAGENT LOT 10580LF00, (B)(6) S/CO, REACTIVE. REPEAT TESTING, (B)(6) S/CO, REPEAT REACTIVE. REPEAT TESTING ON (B)(6) 2012, REAGENT LOT 12226LF00, DIFFERENT ARCHITECT, RESULT = (B)(6) S/CO, REACTIVE. (B)(6) TESTING, ON (B)(6) 2012, REAGENT LOT 08522LF00: 0.00 IU/ML, NOT REACTIVE, ARCHITECT (B)(4) REPEAT (B)(6) TESTING, ON (B)(6) 2012, REAGENT LOT 10580LF00, (B)(6) IU/ML, ARCHITECT (B)(4) CORE: (B)(6) S/CO, REACTIVE. AUSAB: (B)(6) MIU/ML, NOT REACTIVE. THE SAMPLE WAS NEUTRALIZED IN CONFIRMATORY TESTING. THE CUSTOMER ALSO STATED 14 FALSE (B)(6) WERE GENERATED WHICH GENERATED NEGATIVE RESULTS UPON RETEST. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT, AS THE FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG REAGENT KSJ ABBOTT IRELAND 08522LF00

    Patients

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