BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 20402209 · Received October 8, 2024

    Report

    Report Number
    1823260-2024-02922
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 13, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A COMBINATION OF THE ISSUES FOUND BY THE FIELD SERVICE ENGINEER AND POOR SAMPLE PRE-ANALYTICS. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER WAS 803015. THE CREATININE REAGENT LOT NUMBER AND THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND WHITE DEPOSITS ON THE SAMPLE PROBE. HE REPLACED AND ADJUSTED THE PROBE AND VERIFIED THE WASHING STATION AND VACUUM BOTTLE WERE ACCEPTABLE. THE CUSTOMER PERFORMED CALIBRATION AND QC WHICH WERE BOTH ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. EXAMPLE 1 INITIAL CALCIUM GEN.2 RESULT WAS 1.63 MMOL/L AND THE REPEAT RESULT WAS 2.05 MMOL/L. EXAMPLE 2 INITIAL COBAS CREATININE PLUS VER.2 ASSAY RESULT ON (B)(6) 2024 WAS 172. MOL/L AND THE REPEAT RESULT ON (B)(6) 2024 WAS 93.1 MOL/L. EXAMPLE 3 INITIAL CALCIUM RESULT WAS 1.92 MMOL/L AND THE REPEAT RESULT WAS 1.59 MMOL/L. EXAMPLE 4 INITIAL CALCIUM RESULT WAS 1.77 MMOL/L AND THE REPEAT RESULT WAS 2.28 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718453 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown