BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)

    MDR report key: 9287825 · Received November 6, 2019

    Report

    Report Number
    1219913-2019-00226
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    July 25, 2019
    Report Date
    November 6, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TYPE OF BLOOD COLLECTION TUBE USED WAS LITHIUM HEPARINIZE PLASMA TUBE FROM BD. THE SAMPLE WAS NOT TESTED WITH MULTI-DILUENT 11 WITH THE ATELLICA IM AHBS2 ASSAY. THE PATIENT WAS NOT VACCINATED FOR HEPATITIS B. THE CUSTOMER HAD A PATIENT SAMPLE THAT RECOVERED (B)(6) WITH THE ATELLICA IM ANTI-HBS2 ASSAY ON (B)(6) 2019 BUT WAS (B)(6) ON TWO ALTERNATE METHODS. WHEN THE SAMPLE WAS TESTED ON ANOTHER ATELLICA IM SYSTEM, IT RECOVERED (B)(6). THE SAMPLE WAS ALSO HBSAG (B)(6). THE DATA PROVIDED BY THE CUSTOMER SHOWED THE SAMPLE RECOVERED (B)(6) ON S/N/ (B)(4) WITH ATELLICA IM ANTI-HBS2 LOT 109 ON (B)(6) 2019 AND (B)(6) ON S/N (B)(4) WITH ATELLICA IM ANTI-HBS2 LOT 117 ON (B)(6) 2019. SIEMENS REVIEWED THE CALIBRATION DATA PROVIDED AND THERE IS NO EVIDENCE OF A PROBLEM. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PATIENT'S MEDICAL STATUS OR A LIST OF MEDICATIONS/SUPPLEMENTS THE PATIENT IS TAKING. THERE IS NO SAMPLE THAT CAN BE SENT TO SIEMENS FOR EVALUATION. THE CLINICAL SENSITIVITY AND SPECIFICITY SECTION OF THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) INSTRUCTIONS FOR USE (IFU) (B)(4) LISTS THE 95% CONFIDENCE INTERVAL (CI) FOR RESOLVED RELATIVE SPECIFICITY AS 98.34% - 99.88% SO A CERTAIN NUMBER OF FALSE POSITIVE RESULTS CAN BE EXPECTED FOR THIS ASSAY. THIS ONE (B)(6) RESULT DOES NOT INDICATE A PRODUCT PROBLEM WITH ATELLICA IM ANTI-HBS2 LOTS 109 AND 117. THE CAUSE OF THE (B)(6) RESULT SEEN BY THE CUSTOMER WHEN USING ATELLICA IM ANTI-HBS2 LOTS 109 AND 117 COULD NOT BE DETERMINED BUT SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." MDR 1219913-2019-00224, 1219913-2019-00225 AND 1219913-2019-00227 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A (B)(6) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE HBSAG RESULT FOR THE PATIENT SAMPLE WAS (B)(6). THE CUSTOMER TESTED THE PATIENT SAMPLE ON TWO ALTERNATE METHODS AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS RUN ON ANOTHER ATELLICA IM SYSTEM BY THE SIEMENS' FIELD APPLICATION SPECIALIST (FAS) AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS RUN ON BOTH ATELLICA IM SYSTEMS ON ANOTHER DAY AND THE RESULTS WERE (B)(6). THE (B)(6) RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE AHBS2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079118 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) AHBS2 IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 109 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1