BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 24627982 · Received March 18, 2026

    Report

    Report Number
    1823260-2026-00976
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    UDI-DI
    07613336121160
    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 ANALYZER'S SERIAL NUMBER IS (B)(6). THE ALARM TRACE SHOWED ABNORMAL ASPIRATION" ALARMS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL PRODUCT PROBLEM WAS EXCLUDED. PRE-ANALYTICAL ISSUES COULD NOT BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 555 MOL/L, AND THE REPEATED RESULT WAS 525 MOL/L. THE PHYSICIAN QUESTIONED THE RESULTS, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 641 MOL/L, 65.3 MOL/L, 366 MOL/L, 368 MOL/L, 367 MOL/L, 367 MOL/L, AND 368 MOL/L. A SECOND SAMPLE (COLLECTED AT THE SAME TIME AS THE FIRST SAMPLE) FROM THE SAME PATIENT WAS TESTED, AND THE RESULTS WERE 65.0 MOL/L, 65.3 MOL/L, 65.3 MOL/L, 66.5 MOL/L, 66.2 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28660 CREATININE PLUS VER.2 CREATININE TEST SYSTEM JFY ROCHE DIAGNOSTICS 91675101 07613336121160

    Patients

    Seq Age Sex Outcome Treatment
    1