BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 513 ANALYZER

    MDR report key: 22317944 · Received June 24, 2025

    Report

    Report Number
    1823260-2025-01924
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946327
    PMA / PMN Number
    K160571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT'S LOT NUMBER IS 801605. THE EXPIRATION DATE IS OCTOBER 2025. THE FIELD SERVICE REPRESENTATIVE CLEANED THE HYDRAULIC CIRCUIT OF THE REAGENT AND SAMPLE SUPPLIES, REPLACED THE NEEDLES, REPLACED THE SYRINGE SEALS, CLEANED THE NEEDLES AND RINSE TUBING, AND PERFORMED TESTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    GENERAL REAGENT ISSUES WERE EXCLUDED. THE FIELD SERVICE REPRESENTATIVE PERFORMED MONTHLY MAINTENANCE, ADJUSTMENTS, CLEANINGS, AND REPLACED VALVES, THE PRINTED CIRCUIT BOARD RELAY, THE DEGASSER BATH AND TANK, AND THE REAGENT PROBE. HE PERFORMED CHECKS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS (B)(4). THE HIGH RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULT WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972269 COBAS C 513 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown