BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 23041633 · Received September 12, 2025

    Report

    Report Number
    1823260-2025-02866
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336220153
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER WAS 861168. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. A REVIEW OF ALARM TRACE DATA SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS NEAR THE TIME OF THE EVENT. THE FIELD SERVICE ENGINEER DETERMINED THAT THERE WAS AN ISSUE WITH THE REAGENT PACK; THE CUSTOMER STATED THAT SOME OF THE REAGENTS COULD HAVE BEEN LEFT ON THE DOCK AND NOT STORED CORRECTLY. THE CUSTOMER HAD ALSO USED THE INCORRECT CALIBRATOR LOT FOR CALIBRATION. THE REAGENT PACK WAS REPLACED, AND THE INFORMATION FOR THE CORRECT CALIBRATOR LOT WAS DOWNLOADED ONTO THE ANALYZER. CALIBRATION, CONTROLS, AND PRECISION STUDIES WERE PERFORMED WITH NO ISSUES. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ON A COBAS C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 2.1 MG/DL. SINCE THE VALUE WAS A CRITICAL LOW RESULT, THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 10.1 MG/DL AND THIS VALUE WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534760 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336220153

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female