BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 8764660 · Received July 5, 2019

    Report

    Report Number
    3008344661-2019-00080
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    May 23, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT TICKET SEARCHES IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR LOT 94053FN00. COMPLAINT TRENDING REPORT REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. THE 2 RETURN PATIENT SAMPLE TUBES WERE TESTED USING AN IN-HOUSE RETAINED KIT OF LOT 94053FN00 AND THE HBSAG Q II RESULTS (0.83 AND 0.72 S/CO) MATCHED THE NATURE OF THE CUSTOMER COMPLAINT (NONREACTIVE RESULT). CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 94053FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PREFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR LOT 94053FN00 USING SEARCH OF THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. A REVIEW OF PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. USING WORLDWIDE DATA A REVIEW OF CUSTOMER FIELD DATA WAS PERFORMED FOR THE ASSAY WHICH SHOWED NO ATYPICAL PERFORMANCE FOR THE LOT. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTION LOT NUMBER AND SECTION AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED THAT THE ACCOUNT STATED THE HEPATITIS B POSITIVE DONOR OBTAINED A NEW SAMPLE WHICH GENERATED PCR POSITIVE RESULTS BUT ARCHITECT METHOD NEGATIVE (0.97 S/CO) AND REACTIVE (1.05 S/CO) RESULTS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 2G22, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 4P53. PATIENT IDENTIFIER, DOES NOT CONTAIN ENOUGH SPACES, FULL ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED (B)(6) ON A DONOR ((B)(6) YEAR OLD NON-CAUCASIAN MALE) ID (B)(6) ON (B)(6) 2019. ADDITIONALLY, THE DONOR TESTED (B)(6), MUREX (B)(6), BIORAD (B)(6). NO IMPACT TO PATIENT/DONOR WAS REPORTED. NO ADDITIONAL SPECIFIC PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558195 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 94053FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR ARCHITECT LIST 03M74-02| ARCHITECT LIST 03M74-02| ARCHITECT LIST 03M74-02| SERIAL (B)(4)| SERIAL (B)(4)| SERIAL (B)(4)