BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 21240663 · Received January 27, 2025

    Report

    Report Number
    1823260-2025-00234
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER CHECKED THE GEAR PUMP, WATER PRESSURE, RINSE LEVELS, AND RAN A HARDWARE CHECK. THE HARDWARE CHECK PASSED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ALBUMIN, GLUCOSE HK GEN. 3, AND TOTAL PROTEIN. THE CUSTOMER OBSERVED A NEGATIVE BIAS FOR CALCULATED TESTS, SO THEY DECIDED TO REPEAT THE PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON A SECOND ANALYZER AND THE REPEAT VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.5 G/DL AND IT REPEATED AS 3.4 G/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 6.5 G/DL AND IT REPEATED AS 17.1 G/DL. THE THIRD SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.5 G/DL AND IT REPEATED AS 3.7 G/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 6.2 G/DL AND IT REPEATED AS 7.4 G/DL. THIS SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 64 MG/DL AND IT REPEATED AS 114 MG/DL. THE FIFTH SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 6.10 G/DL AND IT REPEATED AS 7.4 G/DL. THE SIXTH SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 1.7 G/DL AND IT REPEATED AS 3.7 G/DL. THIS SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 5.6 G/DL AND IT REPEATED AS 7 G/DL. THE SEVENTH SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 4.8 G/DL AND IT REPEATED AS 7.4 G/DL. THE EIGHTH SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 2.8 G/DL AND IT REPEATED AS 3.5 G/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830416 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown