BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 7086082 · Received December 6, 2017

    Report

    Report Number
    1823260-2017-02852
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 17, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES (SERUM AND PLASMA) WERE RECEIVED FOR INVESTIGATION AND TESTED ON A COBAS 8000 C 702 MODULE FOR BOTH CREJ2 CREATININE JAFFÉ GEN.2 AND CREP2 CREATININE PLUS VER.2. THE CREATININE RESULTS FOR BOTH SAMPLES AND BOTH METHODS WERE SIMILAR. BASED ON THESE RESULTS, THE CUSTOMER RESULTS WERE CONFIRMED. ALL RESULTS FOR IGG WERE WITHIN THE NORMAL RANGE, THE RESULTS FOR IGA WERE SLIGHTLY ABOVE THE REFERENCE RANGE, AND THE RESULT OF IGM WAS INCREASED. DUE TO THE HIGH CONCENTRATION OF IMMUNOGLOBULIN, POSSIBLE IGM INTERFERENCE EXISTS. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. AS CALIBRATION AND QC RESULTS WERE ACCEPTABLE, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAS A GAMMOPATHY. PRODUCT LABELING FOR THE ASSAY DOCUMENTS THIS INTERFERENCE. AS THE REACTION KINETICS FOR THE ERRONEOUS RESULTS WERE NOT AVAILABLE, THIS INTERFERENCE COULD NOT BE CONFIRMED TO BE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW CREP2 CREATININE PLUS VER. 2 RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS 57.5 UMOL/L FROM BOTH SERUM AND PLASMA SAMPLES. ON A SIEMENS ANALYZER, THE RESULT WAS 187.23 UMOL/L FROM THE PLASMA SAMPLE AND 190.02 UMOL/L FROM THE SERUM SAMPLE. ON A BECKMAN ANALYZER, THE RESULT WAS 164 UMOL/L FROM THE PLASMA SAMPLE AND 169 UMOL/L FROM THE SERUM SAMPLE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 283369. THE EXPIRATION DATE WAS REQUESTED BUT AS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868718 CREATININE PLUS VER.2 ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS C701 283369

    Patients

    Seq Age Sex Outcome Treatment
    1