BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 16388841 · Received February 16, 2023

    Report

    Report Number
    1823260-2023-00481
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 19, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336121528
    PMA / PMN Number
    K191899
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTEDLY THE CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE AT THE TIME OF TESTING. THE CUSTOMER WAS CONCERNED THE RESULT HAD A "HU" DATA FLAG. PER PRODUCT LABELING: "HU - ALARM: HIGHER UNCERTAINTY, DESCRIPTION: THE RESULT LIES BETWEEN THE LIMIT OF DETECTION (LOD) AND THE LIMIT OF QUANTITATION (LOQ)., CAUSE: THE SAMPLE CONCENTRATION IS TOO LOW., REMEDY: 1. FOR SPECIFIC C 503 TESTS: REPEAT THE TEST WITH INCREASED SAMPLE VOLUME, IF AVAILABLE FOR THE TEST. CHECK THE SAMPLE VOLUMES ON MENU > APPLICATION. 2. FOR ISE AND C 503 TESTS: PERFORM MAINTENANCE > 18 SAMPLE PROBE WASH. 3. REPEAT THE TEST WITH A NEW ALIQUOT." THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TP2 (TOTAL PROTEIN GEN. 2) ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TP2 VALUE OF 0.3 G/DL, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED. THE SAMPLE WAS REPEATED RESULTING IN A VALUE OF 7.0 G/DL, WHICH WAS DEEMED CORRECT. THE TP2 REAGENT LOT WAS 63565201 WITH AN EXPIRATION DATE OF 31-JUL-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373750 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C503 NA 07613336121528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown