BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22564485 · Received July 22, 2025

    Report

    Report Number
    1823260-2025-02232
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 21, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE CLOT TIME WAS SHORT. THE FIELD SERVICE ENGINEER PERFORMED SOME TROUBLESHOOTING ACTIONS. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE AND WITH A HARDWARE-RELATED ISSUE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Additional Manufacturer Narrative · 0

    THE CREP2 REAGENT USED TO TEST SAMPLE 1 HAD A LOT NUMBER OF 853138. THE EXPIRATION DATE WAS NOT PROVIDED. THE CREP2 REAGENT USED TO TEST SAMPLE 2 HAD A LOT NUMBER OF 86354001 WITH AN EXPIRATION DATE OF 31-DEC-2025. CALIBRATION AND QC WERE WITHIN THE RANGE. THE ALARM TRACE SHOWED ALARMS INCLUDING SAMPLE CLOT, SAMPLE FOAM, AND ABNORMAL ASPIRATIONS. ALL THESE ALARMS INDICATE PRE-ANALYTICAL ISSUES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS C 503 ANALYTICAL UNIT. PATIENT (B)(6): INITIAL RESULT: 1.89 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND REQUESTED THE SAMPLE TO BE REPEATED. ON (B)(6) 2025: REPEAT RESULT: 1.02 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. ON (B)(6) 2025: A NEW SAMPLE WAS DRAWN AND TESTED, RESULTING IN A VALUE OF 0.923 MG/DL. PATIENT (B)(6) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 1.60 MG/DL (USING A DIFFERENT REAGENT LOT NUMBER). ON (B)(6) 2025: REPEAT RESULT: 0.684 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901287 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS D355231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown