BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23168960 · Received September 29, 2025

    Report

    Report Number
    1823260-2025-03945
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 861168. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CLEANED THE TOP OF THE SYRINGE THROUGH THE SAMPLE PROBE AND ADJUSTED THE RINSE MECHANISM VOLUMES. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE QC WAS ACCEPTABLE. THE ALARM TRACE SHOWED "ABNORMAL ASPIRATION (SAMPLE PIPETTER)" ALARMS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS APPROXIMATELY 11 MG/DL. THE REPEATED RESULT WAS 8.82 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524686 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown