BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19033456 · Received April 3, 2024

    Report

    Report Number
    1219913-2024-00279
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    February 14, 2024
    Report Date
    June 11, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    K192790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED SATES REPORTED OBSERVATION OF A REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE ATELLICA IM AHBS2 INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2024-00279 WAS INITIALLY SUBMITTED ON 03-APR-2024. SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED SATES REPORTED OBSERVATION OF A REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. INITIAL TESTING USING AHBS2 IN FEBRUARY AND MARCH WAS REPRODUCIBLY REACTIVE, ACROSS THREE SAMPLES AND TWO ATELLICA IM INSTRUMENTS. SIEMENS INVESTIGATION INCLUDED REVIEW OF CUSTOMER ASSAY AND INSTRUMENT DATA. REAGENT ISSUES WERE RULED OUT, AS QUALITY CONTROL (QC) RESULTS WERE WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED FOR OTHER PATIENT SAMPLES. NO ISSUES WERE IDENTIFIED WITH ASSAY CALIBRATION. IN (B)(6), THE CUSTOMER PERFORMED FOLLOW-UP TESTING, TREATING ONE OF THE DISCORDANT SAMPLES USING A NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND A HETEROPHILIC BLOCK TUBE (HBT). BOTH PRE-TREATED SAMPLES PRODUCED MUCH LOWER (NONREACTIVE) AHBS2 RESULTS: INITIAL (DISCORDANT) RESULT: 105 IU/L (REACTIVE, = 12.0 MIU/ML) WITH NABT TUBE: 3.10 IU/L (NONREACTIVE, < 8.0 MIU/ML) WITH HBT TUBE: 4.82 IU/L (NONREACTIVE, < 8.0 MIU/ML) FOLLOW-UP TESTING INDICATES THAT THE PROBABLE CAUSE FOR THE DISCORDANT RESULT IS A SAMPLE-SPECIFIC INTERFERENT. RETURN OF THE PATIENT SAMPLE FOR FURTHER INTERNAL INVESTIGATION BY SIEMENS IS NOT WARRANTED BECAUSE THE CUSTOMER HAS CONDUCTED APPROPRIATE TESTING. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE CUSTOMER OBTAINED REPRODUCIBLE REACTIVE AHBS2 RESULTS ON THREE TEST DATES FOR A 30-YEAR-OLD MALE PATIENT. REPEAT TESTING USING TWO ALTERNATE METHODS PRODUCED NEGATIVE RESULTS WHICH CONFLICTED WITH THE EARLIER REACTIVE RESULTS. THE CUSTOMER IS UNCERTAIN WHICH RESULTS TO CONSIDER CORRECT. DUE TO THE CONFLICTING INDICATIONS, THE REACTIVE ATELLICA IM AHBS2 RESULTS ARE CONSIDERED POTENTIAL FALSE POSITIVE OBSERVATIONS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES WHEN THESE AHBS2 TESTS WERE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690409 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 164 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male