BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1915182 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07173
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED ANALYZER ALARMS AND RECEIVED QUESTIONABLE RESULTS FOR ALANINE AMINOTRANSFERASE (ALT) AND ASPARTATE AMINOTRANSFERASE (AST) FOR ONE PATIENT SAMPLE. THE USER STATED "BOTH THE ALT AND AST WERE AROUND 55 AND THEN HAD TO BE CORRECTED TO VALUES IN THE TEENS". NO SPECIFIC DATA COULD BE PROVIDED. THE REPEAT TESTING WAS PERFORMED ON ANOTHER COBAS C501 AT THE SITE. THE UNIT OF MEASURE FOR BOTH ASSAYS WAS U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER STATED THEY FILED A CORRECTED REPORT AND CALLED ER AS SOON AS THE ISSUE WAS IDENTIFIED. NO TREATMENT WAS ADMINISTERED BASED ON THE RESULTS. NO ADVERSE EVENTS WERE ALLEGED. THE ALT AND AST REAGENT LOT NUMBERS WERE NOT PROVIDED. THE USER REPLACED THE LAMP WHICH RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1