BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SYPHILIS

    MDR report key: 23303636 · Received October 15, 2025

    Report

    Report Number
    1823260-2025-04201
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    July 1, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LIP
    UDI-DI
    07613336171998
    PMA / PMN Number
    K211302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED DATA SHOWED THAT SEVERAL CALIBRATION EVENTS WERE WITHIN THE EXPECTED RANGES. THE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. THE PRODUCT LABELING STATES: "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." FALSE RESULTS MAY OCCUR IN ELECSY SYPHILIS; SENSITIVITY AND SPECIFICITY ARE LESS THAN 100%. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ELECSYS SYPHILIS ASSAY PERFORMS WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ON E801 ANALYZER SERIAL NUMBER (B)(6), THE CALIBRATION WAS PERFORMED ON (B)(6) 2025. THE QC WAS PERFORMED WITH REAGENT LOT NUMBER 828502 AND WAS WITHIN THE SPECIFIED RANGES. ON E801 ANALYZER SERIAL NUMBER (B)(6), THE QC WAS PERFORMED WITH REAGENT LOT NUMBER 828502 AND WAS WITHIN THE SPECIFIED RANGES. THE SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. MEDWATCH FIELD E1 INITIAL REPORTER ESTABLISHMENT NAME - THE FULL FACILITY NAME WAS PROVIDED AS (B)(6).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS TESTED WITH ELECSYS SYPHILIS ASSAY ON COBAS E 801 MODULE ANALYZERS. THE CUSTOMER ALLEGEDLY STARTED INTERNALLY APPLYING THEIR OWN GREY ZONE FOR THE ELECSYS SYPHILIS ASSAY OF 0.5 - 1.0 COI. SAMPLES WITH RESULTS IN THIS RANGE ARE THEN REPORTEDLY RE-ANALYZED USING THE ABBOTT ARCHITECT METHOD. THE CUSTOMER ALLEGED THAT APPROXIMATELY 15 PATIENT SAMPLES PER DAY FALL WITHIN THIS GREY ZONE RANGE. TWO SAMPLES (SAMPLE 1 AND SAMPLE 2) WERE DRAWN FROM PATIENT 1 AND TESTED ON E 801 ANALYZER SERIAL NUMBER (B)(6). SAMPLE 1 WAS TESTED AND REPORTEDLY RESULTED IN THE FOLLOWING: INITIAL RESULT: 0.849 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS NON-REACTIVE). 1ST REPEAT RESULT: 1.02 S/CO (TESTED WITH ABBOTT AND INTERPRETED AS REACTIVE). 2ND REPEAT RESULT: NEGATIVE (TESTED WITH RAPID PLASMA REAGIN (RPR) METHOD). 3RD REPEAT RESULT: NEGATIVE (TESTED WITH IMMUNO BLOT METHOD). SAMPLE 2 WAS TESTED ON (B)(6) 2025 AND REPORTEDLY RESULTED IN THE FOLLOWING: INITIAL RESULT: 169 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS REACTIVE). 1ST REPEAT RESULT: 170 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS REACTIVE). 2ND REPEAT RESULT: 171 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS REACTIVE). 3RD REPEAT RESULT: 26.72 S/CO (TESTED WITH ABBOTT AND INTERPRETED AS REACTIVE). 4TH REPEAT RESULT: POSITIVE (TESTED WITH RAPID PLASMA REAGIN (RPR) METHOD). 5TH REPEAT RESULT: POSITIVE (TESTED WITH IMMUNO BLOT METHOD). ON (B)(6) 2025, PATIENT 2 WAS TESTED ON E801 ANALYZER SERIAL NUMBER (B)(6) AND REPORTEDLY RESULTED IN THE FOLLOWING: INITIAL RESULT: 0.716 COI (TESTED WITH ELECSYS SYPHILIS AND INTERPRETED AS NON-REACTIVE). REPEAT RESULT: 1.72 S/CO (TESTED WITH ABBOTT AND INTERPRETED AS REACTIVE). FOR PATIENT 1 AND PATIENT 2, ALL BLOOD PRODUCTS DERIVED FROM THESE DONATIONS WERE REPORTEDLY BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005679 ELECSYS SYPHILIS ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ROCHE DIAGNOSTICS SYPHILIS 82850201 07613336171998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown