BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1951113 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00074
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION REVEALED THE FALSELY ELEVATED CREATININE RESULTS MIGHT HAVE BEEN CAUSED BY ACETOACETATE INTERFERENCE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE JAFFE GENERATION 2 RESULTS WHEN COMPARED TO THE CREATININE RESULTS BY AN ENZYMATIC METHOD. THE CREATININE RESULT BY THE JAFFE METHOD WAS 37.5 MG/DL. IN ANOTHER LABORATORY WITH THE ENZYMATIC METHOD ON AN INTEGRA 800 ANALYZER, THE CREATININE RESULT WAS 0.64 MG/DL. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE LOT NUMBER OF THE CREATININE JAFFE REAGENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR DORMICUM