BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS B-CROSSLAPS

    MDR report key: 24444719 · Received February 25, 2026

    Report

    Report Number
    1823260-2026-00688
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 21, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE B-CROSSLAPS REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH ELECSYS B-CROSSLAPS ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM), INCONSISTENT WITH THE PATIENTS' EXPECTED RESULTS AND MEDICAL HISTORY. DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES WERE PROVIDED. PATIENT 1, PATIENT 2, PATIENT 3, AND PATIENT 4 WERE ALL TESTED, RESULTING IN BETA-CROSSLAPS VALUES OF < 10 PG/ML AND ACCOMPANIED BY DATA FLAGS. THE CUSTOMER REPEATED ALL THE SAMPLES, AND THE RESULTS REMAINED ACCOMPANIED BY DATA FLAGS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2026: NEW BLOOD SAMPLES WERE DRAWN AND TESTED, RESULTING IN THE FOLLOWING: PATIENT 1: RESULT: 20 PG/ML. PATIENT 2, PATIENT 3, AND PATIENT 4 RESULTS WERE ALL < 10 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567964 ELECSYS B-CROSSLAPS COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE JMM ROCHE DIAGNOSTICS 911252

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female PATIENT 1: BISPHOSPHONATES (PILLS)| PATIENT 1: PROLIA (INJECTION EVERY 6 MONTHS)| PATIENT 2: BISPHOSPHONATES (PILLS)| PATIENT 2: PROLIA (INJECTION EVERY 6 MONTHS)| PATIENT 3: BISPHOSPHONATES (PILLS)| PATIENT 3: PROLIA (INJECTION EVERY 6 MONTHS)| PATIENT 4: BISPHOSPHONATES (PILLS)| PATIENT 4: PROLIA (INJECTION EVERY 6 MONTHS)