BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24115504 · Received January 20, 2026

    Report

    Report Number
    1823260-2026-00206
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 27, 2025
    Report Date
    March 27, 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

    MEDWATCH FIELD H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, THE COMPONENT CODE WERE UPDATED. CREATININE PLUS VER.2 RESULTS WERE RECEIVED ON 05-MAR-2026 FOR A NEW PATIENT, PATIENT 2. PATIENT 2'S INITIAL CREATININE RESULT ON (B)(6) 2026 WAS 59.1 UMOL/L. THE REPEAT RESULT WAS 82.6 UMOL/L. THE INITIAL RESULT WAS REPEATED AS IT WAS FOUND TO BE INCONSISTENT WITH A PREVIOUS RESULT. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY. THE CREATININE PLUS VER.2 REAGENT LOT NUMBER 916751 WAS USED ON (B)(6) 2026; IT IS NOT PROVIDED IF THIS REAGENT WAS STILL IN USE FOR THE RESULTS OBTAINED ON (B)(6) 2026. THE EXPIRATION DATE WAS NOT PROVIDED. QC WAS PASSING AT THE TIME OF THE EVENT. REAGENT ISSUES WERE EXCLUDED AS THE CUSTOMER HAD NO FURTHER ISSUES, AND THE CORRECT REPEAT RESULT WAS RECEIVED USING THE SAME REAGENT. THE INVESTIGATION DETERMINED THAT THE EVENT WAS DUE TO THE ADJUSTMENT OF THE ULTRASONIC MIXER. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 925242, AND THE EXPIRATION DATE WAS NOT PROVIDED. IN THE ALARM TRACE REPORT, THERE ARE ALARMS FOR WASH SOLUTION SHORT, AS WELL AS ABNORMAL ASPIRATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATINE KINASE RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 5 U/L, ACCOMPANIED BY AN ALARM. THE FIRST REPEAT RESULT WAS 2620 U/L. THIS WAS AN AUTOMATIC RERUN WITH A REDUCED VOLUME. THE SAMPLE WAS REPEATED ON ANOTHER COBAS ANALYZER, AND THE RESULTS WERE 8578 U/L, 8574 U/L, AND 8555 U/L. THE SAMPLE WAS REPEATED ON THE INITIAL ANALYZER AGAIN, YIELDING A RESULT OF 8524 U/L. THIS RESULT WAS WITH A REDUCED VOLUME. THE RESULT OF 8578 U/L WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552217 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown