BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17491392 · Received August 9, 2023

    Report

    Report Number
    1219913-2023-00158
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    June 23, 2023
    Report Date
    September 25, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039-S005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2023-00158 WAS INITIALLY FILED 2023-08-09. UPDATE, 2023-09-21: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES 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 CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE CLINICAL/MEDICAL HISTORY OF THE AFFECTED PATIENT. IT WAS NOTED THAT THE HEPATITIS B SURFACE ANTIGEN II (HBSII) RESULT FOR THIS PATIENT WAS ALSO REACTIVE (POSITIVE). THE CUSTOMER DID NOT TEST THE AFFECTED SAMPLE USING A HETEROPHILIC BLOCKING TUBE TO IDENTIFY POTENTIAL ENDOGENOUS INTERFERENCE. QUALITY CONTROL (QC) RESULTS FOR AHBS2 WERE WITHIN EXPECTED RANGES ON THE DAY OF THE DISCORDANT OBSERVATION. SIEMENS REVIEWED THE COMPLAINT DATABASE AND DID NOT IDENTIFY ANY SIMILAR OBSERVATIONS. BASED ON THE RESULT FROM THE ALTERNATE PLATFORM AND THE OBSERVED REACTIVE RESULT FOR HBSII, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR A SAMPLE-SPECIFIC INTERFERENT AS THE CAUSE OF THE INITIAL DISCORDANT REACTIVE AHBS2 RESULT. THE ASSAY¿S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: ¿RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS.¿ RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE TESTING WAS ALREADY PERFORMED ON AN ALTERNATE PLATFORM FOR CONFIRMATION. THE ASSAY IS PERFORMING AS EXPECTED AND WITHIN SPECIFICATIONS. THE CUSTOMER IS CURRENTLY OPERATIONAL. NO FURTHER ACTION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 161 WAS IN USE AT THE TIME. A REACTIVE (POSITIVE) AHBS2 RESULT WAS OBTAINED FOR A 61-YEAR-OLD MALE PATIENT. [12.62 MIU/ML VS. CUTOFF OF 12 MIU/ML]. ON THE SAME DAY, A STRONGLY-REACTIVE HEPATITIS B SURFACE ANTIGEN (ATELLICA IM HBSII) RESULT WAS OBSERVED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR CONFIRMATION, AND THE ALTERNATE-METHOD RESULT FOR ANTI HBS ANTIBODIES WAS <2.0 MIU/ML (¿ABSENT¿). THE LOWER RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588969 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 161 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male