BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 4140754 · Received October 3, 2014

    Report

    Report Number
    1823260-2014-07610
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE SAMPLE FROM THE PATIENT WAS TESTED ON A COBAS C501 ANALYZER AND AN INTEGRA 800 ANALYZER WITH TWO CREATININE METHODS AND THE RESULTS WERE COMPARABLE TO THE RESULTS OBTAINED BY THE CUSTOMER. BASED ON THESE RESULTS, INTERFERENCE IN THE SAMPLE COULD BE EXCLUDED. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA FOUND THEM ACCEPTABLE. THEREFORE A GENERAL REAGENT ISSUE COULD BE EXCLUDED. A PREANALYTICAL HANDLING ISSUE OR A MISTAKEN SAMPLE IDENTITY AT THE CUSTOMER SITE COULD NOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CREATININE JAFFÉ GEN.2 RESULT FOR TWO PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 4.89 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER COBAS SYSTEM AND THE RESULT WAS 3.52 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2014, THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS 2.56 MG/DL. THE RESULT WITH THE ENZYMATIC CREATININE METHOD WAS 2.48 MG/DL. WITH THE OTHER COBAS SYSTEM, THE CREATININE JAFFÉ RESULT WAS 2.30 MG/DL AND THE RESULT WITH THE ENZYMATIC CREATININE METHOD WAS 2.50 MG/DL. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND WAS TESTED IN A DIFFERENT LABORATORY. THE CREATININE RESULT WAS 0.7 MG/DL. ON (B)(6) 2014, THE PATIENT WAS RECALLED AND A NEW SAMPLE WAS DRAWN. THE CREATININE RESULT WAS 0.7 MG/DL. THE SAMPLE FROM (B)(6) 2014 WHICH HAD BEEN FROZEN WAS MEASURED AGAIN AND THE CREATININE JAFFÈ RESULT WAS 2.56 MG/DL AND THE ENZYMATIC CREATININE METHOD RESULT WAS 2.49 MG/DL. THE RESULT OF 0.7 MG/DL WAS BELIEVED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE JAFFÉ REAGENT LOT NUMBER WAS 699350. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. SAMPLES FROM THE PATIENT WERE SUBMITTED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619903 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1