BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 21491306 · Received February 28, 2025

    Report

    Report Number
    1823260-2025-00582
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SPECIALIST VISITED THE CLIENT AND EVALUATED THE SAMPLE, THEY DETECTED MICRO CLOTS. THERE WERE A LARGE NUMBER OF ABNORMAL ASPIRATION ALARMS IDENTIFIED. SAMPLE HANDLING IS THE MOST LIKELY ROOT CAUSE OF THE QUESTIONABLE CREATININE RESULTS. NO PRODUCT ISSUE WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE PLUS VER.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.380 MG/DL. THE SAMPLE WAS REPEATED MULTIPLE TIMES ON THE COBAS PRO CE AND THE COBAS PRO CEE USING THE SAME SAMPLE WITHOUT A NEW CENTRIFUGE CYCLE. THE FIRST SET OF REPEAT RESULTS FROM THE COBAS PRO CEE WERE 1.08 MG/DL, 1.09 MG/DL, 1.09 MG/DL, 1.09 MG/DL, AND 1.08 MG/DL. THE NEXT REPEAT RESULT WAS 1.12 MG/DL. THE LAST SET OF REPEAT RESULTS WERE 1.12 MG/DL, 1.11 MG/DL, 1.11 MG/DL, AND 1.11 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572294 CREATININE PLUS VER.2 CREATININE TEST SYSTEM JFY ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown