BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23438577 · Received October 31, 2025

    Report

    Report Number
    1823260-2025-04445
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 11, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 882312. THE EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED A DEFECTIVE SAMPLE PROBE. THE FSE VERIFIED THAT THE MODULE WAS WITHIN SPECIFICATIONS. FOLLOWING THE FSE INTERVENTION, NO FURTHER ISSUE WAS OBSERVED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE HK GEN.3 RESULT FOR A PATIENT SAMPLE TESTED ON COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.2 MG/L WITH A DATA FLAG. THE REPEAT RESULT WAS 109 MG/DL. THE TEST WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT ALIGN WITH THE PATIENT'S HISTORY. NO ERRONEOUS RESULT WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562221 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown