BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 24594589 · Received March 13, 2026

    Report

    Report Number
    1823260-2026-00901
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    UDI-DI
    04015630924998
    PMA / PMN Number
    K024098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6), THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE FOLLOWING ALARMS WERE OBSERVED: LL A2-B, LL A1-B, AND OBS.RR. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT ON A COBAS 8000 C702 MODULE. THE FIRST SAMPLE INITIALLY PRODUCED A RESULT OF <5 MOL/L TWO TIMES. THE SAME SAMPLE WAS DILUTED, AND THE RESULTS WITH A 1:5 DILUTION RATIO WERE <5 MOL/L AND <5 MOL/L, <5 MOL/L (INCREASED DILUTION), AND THE RESULT WITH A 1:10 DILUTION RATIO WAS 128 MOL/L. ON (B)(6) 2026, A SECOND SAMPLE WAS OBTAINED FROM THE PATIENT. THE INITIAL RESULT WAS -90.3 MOL/L (REPORTED AS <5 MOL/L). THE SAMPLE WAS DILUTED, AND THE RESULTS WERE -47.8 MOL/L (INCREASED DILUTION) (REPORTED AS <5 MOL/L), AND 139.3 MOL/L WITH A 1:10 DILUTION RATIO. THE SAMPLE WAS TESTED AT ANOTHER SITE ON A COBAS C 502, AND THE RESULT WAS 65 MOL/L. THE RESULT WITH A 1:10 DILUTION RATIO WAS 135 MOL/L. THE PATIENT WAS TESTED IN ANOTHER LABORATORY USING THE BECKMAN ENZYMATIC ASSAY, AND THE RESULT WAS 68 MOL/L WITH A REFERENCE RANGE OF 45-84 MOL/L. IT WAS NOT SPECIFIED IF THIS RESULT WAS OBTAINED FROM A NEW SAMPLE. ON (B)(6) 2026, THE PATIENT WAS THEN TESTED IN ANOTHER LABORATORY USING THE BECKMAN JAFFE ASSAY, AND THE RESULT WAS 54 MOL/L WITH A REFERENCE RANGE OF 49-90 MOL/L. IT WAS NOT SPECIFIED IF THIS RESULT WAS OBTAINED FROM A NEW SAMPLE. INTERFERENCE IS SUSPECTED BECAUSE IT HAS HISTORICALLY BEEN IMPOSSIBLE TO OBTAIN RELIABLE CREATININE RESULTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35751 CREATININE PLUS VER.2 ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS 916764 04015630924998

    Patients

    Seq Age Sex Outcome Treatment
    1