BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY

    MDR report key: 9808210 · Received March 9, 2020

    Report

    Report Number
    1219913-2020-00090
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    December 30, 2019
    Report Date
    April 13, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2020-00090 REPORT ON 09-MAR-2020 FOR A FALSE POSITIVE ATELLICA IM ANTI-HBS2 (AHBS2) RESULT. 20-MAR-2020 - ADDITIONAL INFORMATION: THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PATIENT'S MEDICAL STATUS OR A LIST OF MEDICATIONS/SUPPLEMENTS. THERE IS NO PATIENT SAMPLE AVAILABLE FOR FURTHER EVALUATION BY SIEMENS. THE CLINICAL SENSITIVITY AND SPECIFICITY SECTION OF THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) INSTRUCTIONS FOR USE (IFU) ((B)(4), REVISION 04, 2019-07) LISTS THE 95% CONFIDENCE INTERVAL (CI) FOR RESOLVED RELATIVE SPECIFICITY AS 98.34% - 99.88%. A REVIEW OF INTERNAL DATA INDICATES ATELLICA IM AHBS2 LOTS 123 AND 125 ARE PERFORMING AS INTENDED. THE CAUSE OF THE DISCREPANT RESULTS SEEN BY THE CUSTOMER WHEN USING ATELLICA IM AHBS2 LOTS 123 AND 125 COULD NOT BE DETERMINED, HOWEVER SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. ON 10-APR-2020 - ADDITIONAL INFORMATION: SIEMENS HAS REVIEWED THE EVENT DATA AND HAS CONCLUDED THE INCIDENT INVESTIGATION. CUSTOMER SUPPORT FEEDBACK REGARDING THE INCIDENT INVESTIGATION WAS DEEMED ACCEPTABLE. IN SUMMARY, THE CAUSE OF THE DISCORDANT FALSE POSITIVE ATELLICA IM ANTI-HBS2 (AHBS2) RESULT OBSERVED BY THE CUSTOMER WHEN USING ATELLICA IM AHBS2 LOT 123 IS UNKNOWN, HOWEVER SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE ASSAY IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SECTION H6 RESULTS AND CONCLUSION CODE WAS UPDATED TO REFLECT THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, (B)(6) ATELLICA IM ANTI-HBS2 (AHBS2) RESULT. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE ACCEPTABLE WHEN TESTING WAS PERFORMED. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 1

    A (B)(6) ATELLICA IM ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT AND REPORTED TO THE PHYSICIAN(S). THE (B)(6) AHBS2 RESULT WAS CONSIDERED DISCORDANT COMPARED TO A (B)(6) AHBS2 NEW SAMPLE RESULT RUN ON A NEW REAGENT LOT. THE ORIGINAL SAMPLE WAS RETESTED ON THE NEW REAGENT LOT AND THE AHBS2 RESULT WAS (B)(6). THE (B)(6) ANTI-HBS RETEST RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM ANTI-HBS2 (AHBS2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271340 ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 123 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1