BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24066727 · Received January 14, 2026

    Report

    Report Number
    1823260-2026-00174
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 25, 2025
    Report Date
    March 20, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE PASSING AT THE TIME OF THE EVENT. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT OR ANALYZER. THE CUSTOMER'S CENTRIFUGE TIME MAY BE TOO SHORT, AND THE SPEED MAY BE TOO HIGH PER THE MANUFACTURER'S RECOMMENDED GUIDELINES. THIS CAN BE CONSISTENT WITH PRE-ANALYTICAL ISSUES. IN THE ALARM TRACE REPORT, THERE WERE ALARMS FOR ABNORMAL ASPIRATION, WHICH CAN ALSO BE CONSISTENT WITH A PRE-ANALYTICAL ISSUE. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DID NOT FIND A ROOT CAUSE FOR THE CUSTOMER'S ISSUE. THE INSTRUMENT PERFORMANCE WAS VERIFIED, AND THE ISSUE APPEARS TO BE RESOLVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES SINCE THE SERVICE VISIT WAS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE GLUCOSE HK GEN.3 REAGENT LOT NUMBER IS 882312; THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE HK GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 15 MG/DL, AND THE REPEAT RESULT ON ANOTHER C 503 WAS 143 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE CUSTOMER FOUND THE INITIAL RESULT TO BE QUESTIONABLE AND REPEATED IT. THE INITIAL RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129254 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown