BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8107615 · Received November 27, 2018

    Report

    Report Number
    1219913-2018-00279
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 20, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00279 ON NOVEMBER 27, 2018. SIEMENS FILED THE MDR 1219913-2018-00279 SUPPLEMENTAL REPORT 1 ON DECEMBER 17, 2018. ON 02/05/2019 ADDITIONAL INFORMATION: THE CUSTOMER HAD SAMPLES THAT WERE REPEATEDLY REACTIVE WITH THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) REAGENT LOT 087 BUT NONREACTIVE WHEN TESTED WITH AN ALTERNATE METHOD. ALL OF THE SAMPLES WERE REACTIVE (>1000 INDEX) WITH THE ATELLICA IM HEPATITIS B SURFACE ANTIGEN (HBS) ASSAY. ONE OF THE SAMPLES WAS TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT) AND AFTER TREATMENT THE RESULT WAS NONREACTIVE WITH ATELLICA IM AHBS2 REAGENT LOT 087. ALTHOUGH THE RESULT CHANGED AFTER HBT TREATMENT THERE ARE NO ANTIBODIES IN THE ARCHITECTURE OF THE ATELLICA IM AHBS2 ASSAY, SO HETEROPHILIC ANTIBODIES ARE NOT CAUSING THE REACTIVE ATELLICA IM AHBS2 RESULTS. THE PATIENTS ARE UNDERGOING TREATMENT BUT IT IS UNKNOWN WHICH MEDICINE THEY ARE TAKING. THE SAMPLES WERE NOT AVAILABLE FOR ADDITIONAL TESTING. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE REACTIVE RESULTS, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR SAMPLE ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00277 SUPPLEMENTAL REPORT 2, MDR 1219913-2018-00278 SUPPLEMENTAL REPORT 2, MDR 1219913-2018-00280 SUPPLEMENTAL REPORT 2, MDR 1219913-2018-00281 SUPPLEMENTAL REPORT 2, MDR 1219913-2018-00282 SUPPLEMENTAL REPORT 2, AND MDR 1219913-2018-00283 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00279 ON NOVEMBER 27, 2018. ON 11/30/2018 ADDITIONAL INFORMATION: ALL THE SAMPLES THAT TESTED POSITIVE FOR AHBS2 WERE HBSAG POSITIVE SAMPLES THAT WERE OVER 1000 WITH ATELLICA IM PLATFORM. THE PATIENTS ARE UNDER TREATMENT. IT IS UNKNOWN WHAT MEDICINE IS BEING TAKEN. THE PATIENT SAMPLES ARE NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. SIEMENS HEALTHCARE DIAGNOSTICS IS AWAITING FURTHER INFORMATION. MDR 1219913-2018-00277 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00278 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00280 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00281 SUPPLEMENTAL REPORT 1, MDR 1219913-2018-00282 SUPPLEMENTAL REPORT 1, AND MDR 1219913-2018-00283 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. 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 1219913-2018-00277, MDR 1219913-2018-00278, MDR 1219913-2018-00280, MDR 1219913-2018-00281, MDR 1219913-2018-00282, AND MDR 1219913-2018-00283 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    DISCORDANT (B)(6) RESULTS WERE OBTAINED FOR THREE PATIENTS FROM THE SAME RUN ON THE SAME READYPACK ON THE SAME DAY UPON RETEST. THE PATIENT SAMPLES WERE TESTED PREVIOUSLY ON DIFFERENT READYPACKS AND THE RESULTS WERE (B)(6). THE CUSTOMER SENT OUT THE PATIENT SAMPLES TO BE TESTED WITH AN ALTERNATE INSTRUMENT. THE RESULTS WERE (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944826 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) AHBS2 IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 63041087 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1