BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SYPHILIS

    MDR report key: 23303384 · Received October 15, 2025

    Report

    Report Number
    1823260-2025-04202
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LIP
    UDI-DI
    07613336171950
    PMA / PMN Number
    K211302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES FOR BOTH PATIENTS WERE RECEIVED FOR INVESTIGATION. THE NON-REACTIVE RESULTS OF PATIENT A AND B WERE REPRODUCED AS NON-REACTIVE WITH THE ELECSYS SYPHILIS ASSAY AND CONFIRMED NON-REACTIVE USING IMMUNOBLOT TESTING. THE INVESTIGATION DETERMINED THAT THE ASSAY PERFORMED WITHIN SPECIFICATION, AS FALSE REACTIVE RESULTS MAY OCCUR WITH A SPECIFICITY OF LESS THAN 100%. PER LABELING, "SAMPLES WITH A CUTOFF INDEX = 1.00 ARE CONSIDERED REACTIVE IN THE ELECSYS SYPHILIS ASSAY. INITIALLY REACTIVE SAMPLES GIVING CUTOFF INDEX VALUES OF = 1.00 IN EITHER OF THE RETESTS ARE CONSIDERED REPEATEDLY REACTIVE. REPEATEDLY REACTIVE SAMPLES MUST BE SUPPLEMENTED ACCORDING TO RECOMMENDED CONFIRMATORY ALGORITHMS. REACTIVE TREPONEMAL TEST RESULTS ALONE ARE NOT DIAGNOSTIC OF SYPHILIS, TREPONEMAL TEST RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH ADDITIONAL TREPONEMAL OR NONTREPONEMAL SEROLOGIC TEST RESULTS (AS APPROPRIATE), MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS, AS RECOMMENDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SEXUALLY TRANSMITTED DISEASES TREATMENT GUIDELINES."

    Additional Manufacturer Narrative · 0

    THE COBAS E 602 MODULE SERIAL NUMBER IS (B)(6). THE CALIBRATION WAS WITHIN THE EXPECTED RANGE PRIOR TO THE EVENT. IT IS NOT CONFIRMED IF THE QC WAS PASSING PRIOR TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS SYPHILIS RESULTS FROM THE COBAS E 602 MODULE FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT ON (B)(6) 2025 WAS 4.67 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED ON (B)(6) 2025 TO TEST FOR TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) AND TOLUIDINE RED UNHEATED SERUM TEST (TRUST), BOTH OF WHICH WERE NEGATIVE. A THIRD SAMPLE WAS COLLECTED ON (B)(6) 2025, AND THE INITIAL RESULT WAS 0.86 COI (NON-REACTIVE), AND THE REPEAT RESULT WAS 0.787 COI (NON-REACTIVE) PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 4.5 COI (REACTIVE). A SECOND SAMPLE WAS COLLECTED ON (B)(6) 2025 TO TEST FOR TREPONEMA PALLIDUM PARTICLE AGGLUTINATION (TPPA) AND TOLUIDINE RED UNHEATED SERUM TEST (TRUST), BOTH OF WHICH WERE NEGATIVE. THE SYPHILIS RESULT WAS 0.474 COI (NON-REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288326 ELECSYS SYPHILIS TREPONEMA PALLIDUM ASSAY LIP ROCHE DIAGNOSTICS SYPHILIS 855502 07613336171950

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female PT1 - CRYOPRECIPITATE| PT1 - HUMAN ALBUMIN| PT1 - HUMAN IMMUNOGLOBULIN| PT1 - PLASMA| PT2 - HEPARIN