BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATINE KINASE

    MDR report key: 25170561 · Received May 14, 2026

    Report

    Report Number
    1823260-2026-01901
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHS
    UDI-DI
    07613336121122
    PMA / PMN Number
    K160570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYZER A THE COBAS C 503 ANALYTICAL UNIT'S SERIAL NUMBER IS (B)(6). THE CREATINE KINASE REAGENT LOT NUMBER IS 918559. ANALYZER B THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS NOT PROVIDED. THE CREATINE KINASE REAGENT LOT NUMBER IS 925242.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR CREATINE KINASE ON TWO COBAS C 503 ANALYTICAL UNITS (ANALYZER A AND ANALYZER B). PATIENT SAMPLE 1 RESULTS FROM ANALYZER A: THE INITIAL RESULT WAS 18871 U/L WITH AN INVALIDATING DATA FLAG. THE FIRST REPEAT RESULT IN THE DECREASED MODE WAS 30879 U/L WITH AN INVALIDATING DATA FLAG. THE SECOND REPEAT RESULT WAS 5253 U/L WITH AN INVALIDATING DATA FLAG. THE THIRD REPEAT RESULT WAS 4433 U/L WITH AN INVALIDATING DATA FLAG. THE FOURTH REPEAT RESULT WAS 3275 U/L WITH AN INVALIDATING DATA FLAG. THE FIFTH REPEAT RESULT AT 1:100 MANUAL DILUTION WAS 3548 U/L, WITH A FINAL CALCULATED RESULT OF 354800 U/L. THE SIXTH REPEAT RESULT IN THE DECREASED MODE WAS 31213 U/L WITH AN INVALIDATING DATA FLAG. THE SEVENTH REPEAT RESULT AT A 1:50 DILUTION WAS 32345 U/L WITH AN INVALIDATING DATA FLAG. RESULTS FROM ANALYZER B: THE EIGHTH REPEAT RESULT AT 1:50 MANUAL DILUTION WAS 870 U/L WITH A FINAL CALCULATED RESULT OF 43500 U/L. THE NINTH REPEAT RESULT WAS -0.726 WITH AN INVALIDATING DATA FLAG. THE TENTH REPEAT RESULT AT A 1:50 ANALYZER DILUTION WAS 32617 U/L. THE REPORTED RESULT WAS >200000 U/L, BASED ON THE RESULT OF 354800 U/L. PATIENT SAMPLE 2 RESULTS FROM ANALYZER A: THE INITIAL RESULT WAS 7835 U/L WITH AN INVALIDATING DATA FLAG. THE FIRST REPEAT RESULT IN THE DECREASED MODE WAS 27647 U/L WITH AN INVALIDATING DATA FLAG. THE SECOND REPEAT RESULT WAS 6145 U/L WITH AN INVALIDATING DATA FLAG. THE THIRD REPEAT RESULT IN THE DECREASED MODE WAS 27578 U/L WITH AN INVALIDATING DATA FLAG. THE FOURTH REPEAT RESULT AT 1:100 MANUAL DILUTION WAS 347 U/L, WITH A FINAL CALCULATED RESULT OF 34700 U/L. RESULT FROM ANALYZER B: THE FIFTH REPEAT RESULT AT 1:50 DILUTION WAS 28491 U/L. THE REPORTED RESULT WAS 34700 U/L. AN INTERFERENCE IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611515 CREATINE KINASE CPK, DIFFERENTIAL RATE KINETIC METHOD JHS ROCHE DIAGNOSTICS 918559, 925242 07613336121122

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male ACETAMINOPHEN| AMOXICILLIN