BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 501 MODULE

    MDR report key: 13890865 · Received March 24, 2022

    Report

    Report Number
    1823260-2022-00842
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 27, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAD FLUCTUATING QC FROM (B)(6) 2022 UNTIL (B)(6) 2022, BUT QC WAS WITHIN SPECIFICATION BEFORE THE ALLEGED PATIENT RESULTS WERE PERFORMED ON THE DATE OF THE EVENT. THE CUSTOMER'S CALIBRATION WAS OK. THERE WAS NO INDICATION OF A REAGENT ISSUE. THE FIELD SERVICE REPRESENTATIVE FOUND A BENT SAMPLE PROBE THAT HAD COLLIDED WITH THE DRYING HOLE. HE CHECKED THE SYRINGES, REPLACED THE SAMPLE PROBE, PERFORMED ADJUSTMENTS, AND RAN PERFORMANCE TESTS WITH RESULTS BEING WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UA2 URIC ACID VER.2 RESULTS FOR 9 PATIENT SAMPLES ON A COBAS C 501 MODULE. PATIENT A: THE INITIAL RESULT WAS 569 MOL/L AND THE REPEATED RESULT WAS 406 MOL/L. PATIENT B: THE INITIAL RESULT WAS 537 MOL/L AND THE REPEATED RESULT WAS 380 MOL/L. PATIENT C: THE INITIAL RESULT WAS 551 MOL/L AND THE REPEATED RESULT WAS 403 MOL/L. PATIENT D: THE INITIAL RESULT WAS 469 MOL/L AND THE REPEATED RESULT WAS 337 MOL/L. PATIENT E: THE INITIAL RESULT WAS 433 MOL/L AND THE REPEATED RESULT WAS 314 MOL/L. PATIENT F THE INITIAL RESULT WAS 481 MOL/L AND THE REPEATED RESULT WAS 344 MOL/L. PATIENT G: THE INITIAL RESULT WAS 465 MOL/L AND THE REPEATED RESULT WAS 334 MOL/L. PATIENT H: THE INITIAL RESULT WAS 512 MOL/L AND THE REPEATED RESULT WAS 369 MOL/L. PATIENT I: THE INITIAL RESULT WAS 515 MOL/L AND THE REPEATED RESULT WAS 377 MOL/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULTS WERE PERFORMED ON A ANOTHER C501 MODULE AND WERE BELIEVED TO BE CORRECT. THE REAGENT LOT NUMBER IS 589649 WITH AN EXPIRATION DATE OF 31-OCT-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311218 COBAS C 501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown