BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2574843 · Received May 15, 2012

    Report

    Report Number
    1823260-2012-02588
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    April 24, 2012
    Report Date
    July 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE. THE SERVICE ENGINEER CHECKED THE INSTRUMENT AND PERFORMED PRECISION TESTING, BUT COULD NOT FIND THE ROOT CAUSE. A RANDOM CHECKING OF SAMPLES IN THE LABORATORY FOUND MANY TUBES WITH GEL-LIKE SUBSTANCES AND OILS ON THE SAMPLES. NO PATIENTS WERE ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ABOUT THE PATIENT'S RESULTS. THE INITIAL RESULT WAS 0.02 MG/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 39.16 MG/L.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE C-REACTIVE PROTEIN GEN.3 (CRP) RESULT ON THEIR C501 ANALYZER. THE PATIENT'S INITIAL CRP RESULT WAS 0.2 MG/L. THE CUSTOMER AUTOMATICALLY REPEATS SAMPLES WITH RESULTS LESS THAN 0.41 MG/L, SO THE SAMPLE WAS RE-TESTED BEFORE SENDING THE RESULT TO THE MEDICAL WARD. THE REPEAT RESULT WAS 39 MG/L. IT IS UNCLEAR WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS UNKNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. THE CRP REAGENT LOT NUMBER WAS 653174 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1