BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24764512 · Received April 2, 2026

    Report

    Report Number
    1823260-2026-01236
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER WAS 916751, THE CRP REAGENT LOT NUMBER WAS 926379, AND THE ALP REAGENT LOT NUMBER WAS 935593. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE MAIN WATER PRESSURE WAS FINE. THE FIELD SERVICE ENGINEER FOUND A CLOGGED SAMPLE PROBE, SO IT WAS REPLACED. A WASH STATION WAS RETROFITTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NO FURTHER ISSUES WERE REPORTED AFTER THE PERFORMED SERVICE ACTIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2, A SECOND PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV, AND A THIRD PATIENT SAMPLE TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 195 UMOL/L AND IT REPEATED AS 110 UMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 255 MG/L ND IT REPEATED AS 2.27 MG/L. THE THIRD SAMPLE RESULTED IN THE FOLLOWING ALP VALUES ON (B)(6) 2026: 52 U/L, 54 U/L, 54 U/L, 54 U/L, 61 U/L, AND 177 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1