BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 17636320 · Received August 28, 2023

    Report

    Report Number
    1823260-2023-02788
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    July 31, 2023
    Report Date
    October 12, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL RESULTS WERE DEEMED NOT CLINICALLY POSSIBLE AS THE ALBUMIN RESULT WAS HIGHER THAN THE TOTAL PROTEIN RESULT. THE FIELD SERVICE ENGINEER CHANGED THE PROBES, SYRINGE AND THE GEAR-PUMP HEAD (GPH). HE READJUSTED THE WHOLE SYSTEM AND CONFIRMED THAT THE ASSAY AND THE MODULE WERE PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CAUSED BY A SERVICE-TRAINING-RELATED ISSUE. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 717298. THE EXPIRATION DATE IS 31-OCT-2024. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALBP ALBUMIN BCP RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS IT WAS DEEMED NOT CLINICALLY POSSIBLE. THE INITIAL RESULT WAS 86.5. THE REPEAT RESULT WAS 35.0. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338585 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown