BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 4900013 · Received July 8, 2015

    Report

    Report Number
    1823260-2015-03767
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CLARIFIED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE ANALYZER RELEASED RESULTS LABELED AS "LOWER THAN" FOR "SEVERAL PARAMETERS" WITH NO ERROR MESSAGE OR ANY OTHER NOTIFICATION FROM THE ANALYZER. THE CUSTOMER THOUGHT THIS WAS SUSPICIOUS AND PERFORMED REPEAT TESTING. THE RESULTS FROM THE REPEAT TESTING PRODUCED EXPECTED RESULTS WITHOUT MAKING ANY CHANGES TO THE ANALYZER. IT IS NOT KNOWN HOW MANY PATIENTS WERE AFFECTED. NO PATIENT INFORMATION WAS PROVIDED. THE SPECIFIC PARAMETERS WERE NOT PROVIDED. THE ACTUAL VALUES WERE REQUESTED BUT NOT PROVIDED. IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS INFORMATION WAS REQUESTED BUT NOT PROVIDED. IT IS NOT KNOWN IF ANY ADVERSE EVENT OCCURRED. THIS INFORMATION WAS REQUESTED. THE CUSTOMER CHECKED AND CLEANED MULTIPLE ANALYZER PARTS AND THE ISSUE WAS NOT RESOLVED. THE CUSTOMER CHANGED THE SAMPLE PROBE AND BOTH CELL DETERGENTS. AFTER MAKING THESE CHANGES THE ISSUE DID NOT OCCUR ANY LONGER. THE CUSTOMER INDICATES THE SYSTEM IS OPERATING WITHIN SPECIFICATION AND WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442985 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1