BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 23135453 · Received September 24, 2025

    Report

    Report Number
    1823260-2025-03593
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 31, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH AN ISSUE WITH THE CUSTOMER'S WATER SUPPLY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL RESULT WAS 14 MOL/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 83 MOL/L AND 82 MOL/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 134 MOL/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 28 MOL/L AND 135 MOL/L. FOR SAMPLE 3, THE INITIAL RESULT WAS 15 MOL/L. THE SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 28 MOL/L, 86 MOL/L, AND 88 MOL/L. FOR SAMPLE 4, THE INITIAL RESULT WAS 14 MOL/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 62 MOL/L AND 62 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851071 CREATININE PLUS VER.2 CREATININE TEST SYSTEM JFY ROCHE DIAGNOSTICS 88357301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown