BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2871787 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06322
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ALKALINE PHOSPHATASE GENERATION 2 (ALP), CREATINE KINASE (CK) AND C-REACTIVE PROTEIN GENERATION 3 (CRP) RESULTS FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, THE CRP RESULT WAS DISCREPANT. THE INITIAL RESULT WAS 0.00 MG/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER COBAS C501 ANALYZER AND THE RESULT WAS 0.26 MG/DL. THIS RESULT WAS DEEMED TO BE CORRECT. A CORRECTED REPORT WAS ISSUES WITHIN MINUTES, SO THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CRP REAGENT LOT NUMBER WAS 65656401 WITH AN EXPIRATION DATE OF 05/31/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE MAY HAVE BEEN ABNORMAL SAMPLE DETECTION ON THE SIDE OF TUBE. HE ADJUSTED THE SAMPLE MECHANISM. TO VERIFY THE ANALYZER OPERATION, HE RAN DIAGNOSTICS AND RAN A SAMPLE WITHOUT PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR