BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22608456 · Received July 25, 2025

    Report

    Report Number
    1823260-2025-02286
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 2, 2025
    Report Date
    August 28, 2025
    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 ALBUMIN REAGENT LOT NUMBER IS 858773, AND THE EXPIRATION DATE IS 30-NOV-2026. THE CHOLESTEROL REAGENT LOT NUMBER IS 845940, AND THE EXPIRATION DATE IS 31-AUG-2025. THE AST REAGENT LOT NUMBER IS 870799, AND THE EXPIRATION DATE IS 30-APR-2026. THE TOTAL PROTEIN REAGENT LOT NUMBER IS 858705, THE EXPIRATION DATE IS 31-MAY-2026. THE PHOSPHORUS, GGT, CRP, CREATININE (URINE), MICROALBUMIN (URINE), BUN, CREATININE, TOTAL BILIRUBIN, ALT, HDL, AND PREALBUMIN REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) COMPLETED A MECHANISM CHECK, CUP LEVEL CHECK, CHECKED THE CHECK VALVES, THE GEARPUMP, AND THE SAMPLE NEEDLE ADJUSTMENT AND RINSING, ALL WERE OKAY. THE SAMPLE VALVE WAS DIRTY, AND DURING THE SAMPLE NEEDLE RINSING CHECK, HE OBSERVED SPLASHING AND ADJUSTED THE FLOW RATE. CRYSTALS WERE OBSERVED IN THE SONIC WASH STATION. THE FSE COMPLETED VALIDATION TESTS THAT WERE PASSING AS WELL AS A PATIENT CHECK AND COMPARISON THAT WERE ALSO PASSING. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) REPLACED TWO SAMPLE VALVES. THE CUSTOMER HAS NOT REPORTED ANY NEW ISSUES. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHORUS, GGT, CRP, CREATININE (URINE), MICROALBUMIN (URINE), TOTAL PROTEIN (URINE), BUN, CREATININE, TOTAL BILIRUBIN, AST, ALT, CHOLESTEROL, HDL, AND PREALBUMIN RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE UNIT OF MEASUREMENT WAS PROVIDED FOR SOME RESULTS. IT WAS REQUESTED FOR THE REMAINING RESULTS, AND WAS NOT PROVIDED. PLEASE SEE THE ATTACHMENT FOR THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267272 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown