BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1923504 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07405
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ON-GOING ISSUE WITH QUESTIONABLE TINA-QUANT D-DIMER (D-DIMER) RESULTS SINCE (B)(6) 2010 WHEN THEY INSTALLED THE ASSAY ON THIS COBAS 6000 C501 ANALYZER. D-DIMER RESULTS DID NOT CORRELATE WELL BETWEEN THIS ANALYZER AND THE CUSTOMER'S COBAS C311. THE FIELD APPLICATION SPECIALIST PROVIDED CORRELATION RESULTS FOR FIVE RANDOM SAMPLES SHE RAN ON BOTH THE COBAS 6000 C501 AND THE COBAS C311. RESULTS FOR THREE OF THE SAMPLES WERE DISCREPANT. SAMPLE 1, THE COBAS C311 RESULT WAS 99 NG/ML. THE COBAS 6000 C501 RESULT WAS 163 NG/ML. SAMPLE 2, THE COBAS C311 RESULT WAS 588 NG/ML. THE COBAS 6000 C501 RESULT WAS 815 NG/ML. SAMPLE 3, THE COBAS C311 RESULT WAS 836 NG/ML. THE COBAS 6000 C501 RESULT WAS 1050 NG/ML. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE D-DIMER REAGENT LOT WAS 63431801. THE FIELD SERVICE REPRESENTATIVES DETERMINED THE CAUSES WERE WORN AND DAMAGED SYRINGE SEALS AND INSTRUMENT CONTAMINATION. A FIELD SERVICE REPRESENTATIVE REPLACED THE SEALS AND DECONTAMINATED THE INSTRUMENT. THE SAMPLE PROBE AND BATH CIRCULATION PUMP WERE ALSO REPLACED. A FIELD SERVICE REPRESENTATIVE PERFORMED SYSTEM DIAGNOSTIC TESTS WHICH WERE SUCCESSFUL. THE FIELD APPLICATION SPECIALIST FOUND THE BIORAD QUALITY CONTROL PRODUCT CONTRIBUTED TO THE QUALITY CONTROL RECOVERY DISCREPANCIES. (IT WAS UNKNOWN IF THE D-DIMER QUALITY CONTROL WAS WITHIN RANGE JUST PRIOR TO GENERATING THE DISCREPANT RESULTS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1