BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS B-CROSSLAPS

    MDR report key: 22309715 · Received June 23, 2025

    Report

    Report Number
    1823260-2025-01920
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    UDI-DI
    07613336171561
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT'S RHEUMATOID FACTOR VALUE WAS 1750 MIU/ML; THIS IS MORE THAN THE THRESHOLD TESTED FOR THE ELECSYS B-CROSSLAPS ASSAY. INTERFERENCES WERE TESTED UP TO THE LISTED CONCENTRATIONS (RHEUMATOID FACTORS: <OR = 1000 IU/ML), AND NO IMPACT ON RESULTS WAS OBSERVED. PRODUCT LABELING STATES: LIMITATIONS - INTERFERENCE. THE EFFECT OF THE FOLLOWING ENDOGENOUS SUBSTANCES AND PHARMACEUTICAL COMPOUNDS ON ASSAY PERFORMANCE WAS TESTED. INTERFERENCES WERE TESTED UP TO THE LISTED CONCENTRATIONS AND NO IMPACT ON RESULTS WAS OBSERVED. ENDOGENOUS SUBSTANCES. COMPOUND: RHEUMATOID FACTORS. CONCENTRATION TESTED: = 1000 IU/ML. THE EVENT IS CONSISTENT WITH A KNOWN INTERFERENCE (RHEUMATOID FACTOR). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS B-CROSSLAPS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: >6 NG/ML (REFERENCE RANGE 0.21-0.44 NG/ML). THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, AND THE SAMPLE WAS MANUALLY DILUTED WITH A LOW-CONCENTRATION SERUM AND REPEATED. THE REPEAT RESULTS WERE AS FOLLOWS: 1ST REPEAT RESULT: >6 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:2). 2ND REPEAT RESULT: 1.94 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:4). 3RD REPEAT RESULT: 0.872 NG/ML (TESTED WITH A DILUTION FACTOR OF 1:8). THE CUSTOMER SUSPECTED AN INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969548 ELECSYS B-CROSSLAPS COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE JMM ROCHE DIAGNOSTICS 807764 07613336171561

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female