BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1589900 · Received January 29, 2010

    Report

    Report Number
    1823260-2010-00580
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KQG
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER HAD A PATIENT SAMPLE FOR D-DIMER (LOT #614895) THAT MEASURED 0.0 NG/ML. A SECOND MEASUREMENT ALSO HAD 0.0 NG/ML RESULT. CUSTOMER EXPERIENCED THIS SAME ISSUE WITH ADDITIONAL PATIENT SAMPLES DURING THE PREVIOUS WEEK BUT DID NOT PROVIDE RESULTS FOR THOSE SAMPLES. A SECOND SAMPLE FROM THIS PATIENT RECOVERED 0.0 NG/ML. CUSTOMER ALSO RAN 3 RANDOM SAMPLES FOR D-DIMER WHICH ALL RECOVERED 0.0 NG/ML. THE ORIGINAL SAMPLE WAS RUN USING A BIOMERIEUX-MINIVIDAS AND THE RESULT WAS 413 NG/ML. PREVIOUS D-DIMER RESULT FOR THE PATIENT WAS 400 NG/ML. LAB USES GREINER CITRATE PLASMA TUBES. NO ADVERSE AFFECTS WERE REPORTED. THE FIELD APPLICATION SPECIALIST VISITED THE LAB AND AFTER RECALIBRATION AND QC, EVERYTHING WAS OK. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER KQG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1