BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HBSAG II

    MDR report key: 23084508 · Received September 18, 2025

    Report

    Report Number
    1823260-2025-03102
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    March 4, 2020
    Report Date
    September 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    UDI-DI
    04015630940028
    PMA / PMN Number
    P160019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 801 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE ELECSYS HBSAG II ASSAY PERFORMED WITHIN SPECIFICATIONS. NO REAGENT-SPECIFIC ISSUE WAS IDENTIFIED, AND THE REAGENT MET ALL DEFINED SPECIFICATIONS. A REVIEW OF CALIBRATION AND QUALITY CONTROL DATA CONFIRMED THAT ALL RESULTS WERE WITHIN EXPECTED RANGES. INTERNAL TESTING OF SEVEN SAMPLES AT THE CIR LABORATORY YIELDED NON-REACTIVE RESULTS IN BOTH THE FIRST AND SECOND MEASUREMENTS, AND NO CONFIRMATORY TESTING WAS DEEMED NECESSARY. THE POSITIVE RESULT REPORTED BY THE CUSTOMER FOR SAMPLE 2 COULD NOT BE REPRODUCED DURING THE INVESTIGATION. ADDITIONALLY, THE PRESENCE OF NEGATIVE COI VALUES WAS DETERMINED TO BE WITHIN THE DEFINED SPECIFICATIONS FOR THE COBAS E 801 MODULE. THE ANALYZER AND ASSAY REMAINED IN OPERATION AT THE CUSTOMER SITE, AND NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE ELECSYS HBSAG II ASSAY ON THE COBAS E 801 MODULE FOR TWO PATIENT SAMPLES. FOR SAMPLE 1, TESTING ON (B)(6) 2020 YIELDED A RESULT OF -0.0942 (NEGATIVE). SUBSEQUENT TESTING ON (B)(6) 2020 PRODUCED RESULTS OF -0.0987 (NEGATIVE), -0.0809 (NEGATIVE), -0.0598 (NEGATIVE), -0.0546 (NEGATIVE), 0.0998 (NEGATIVE), AND -0.114 (NEGATIVE) ACROSS VARIOUS TUBES AND MATRICES, INCLUDING PLASMA AND SERUM. FOR SAMPLE 2, TESTING ON (B)(6) 2020 YIELDED A RESULT OF -0.00032 (NEGATIVE) IN SERUM. ON (B)(6) 2020, TESTING OF THE SAME SAMPLE IN PLASMA PRODUCED A RESULT OF 0.275 (POSITIVE). THE RESULTS WERE NOT CONFIRMED WITH AN HBSAG CONFIRMATORY TEST. NO ADDITIONAL CONFIRMATORY TESTING WAS PERFORMED, AND THE POSITIVE RESULT FOR SAMPLE 2 COULD NOT BE REPRODUCED. THE RESULTS WERE NOT REPORTED TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636090 ELECSYS HBSAG II HEPATITIS B TEST LOM ROCHE DIAGNOSTICS 42036900 04015630940028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown