BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1593245 · Received February 3, 2010

    Report

    Report Number
    1823260-2010-00748
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJJ
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED OUT AN ERRONEOUS ALT RESULT OF 536 U/L FOR ONE PATIENT SAMPLE. SAMPLE TYPE IS PLASMA. ERRONEOUS RESULT WAS GENERATED FROM A SAMPLE ALIQUOTTED BY AN MPA SYSTEM. ON (B) (6) 2010, THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THE PATIENT BE REDRAWN. THE REDRAWN SAMPLE GAVE 14 U/L. ON (B) (6) 2010 THE ORIGINAL PRIMARY SAMPLE TUBE WAS REPEATED ON ANOTHER C501 ANALYZER SERIAL NUMBER 75202 AT THE SITE GIVING 14 U/L. PHYSICIAN DID NOT ACT ON THE ERRONEOUS ALT RESULT REPORTED. PATIENT WAS NOT ADVERSELY AFFECTED. ALT REAGENT LOT NUMBER, 61893401 THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED. HE ADJUSTED THE SAMPLE PROBE. TO VERIFY ANALYZER PERFORMANCE A PRECISION STUDY WAS RUN WITH NO ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1