BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2961364 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00874
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED INDICATES ALL OF THE RESULTS, BOTH INITIAL TESTING RESULTS AND DILUTED SAMPLE TEST RESULTS WERE ACCOMPANIED BY DATA FLAGS. AN INVESTIGATION WAS PERFORMED USING A SAMPLE ON HAND AT THE MANUFACTURER. THE CUSTOMER'S OBSERVATION WAS CONFIRMED. IT WAS DETERMINED THE 1:5 AND 1:10 TIMES DILUTED SAMPLES WERE HIGHER CONCENTRATED THAN THE ORIGINAL SAMPLE DILUTION WHICH IS PERFORMED BY THE ANALYZER, WHICH IS 1:20. THEREFORE, RESULTS WITHIN THE MEASURING RANGE WERE RECEIVED, HOWEVER WERE ACCOMPANIED BY A DATA FLAG. TESTS RESULTS OBTAINED FROM A MANUALLY PROGRAMMED SAMPLE DILUTION LEADING TO A RESULT WITHIN THE MEASURING RANGE WILL BE MARKED WITH A DATA FLAG NOTIFYING THE USER THERE IS A POSSIBLE ISSUE WITH THE RESULT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE LITHIUM RESULT FOR ONE PATIENT ON THEIR C501 ANALYZER. THE PATIENT'S INITIAL LITHIUM RESULT WAS 3.7 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS MANUALLY DILUTED 1:5 AND THE RESULT WAS 2.1 MMOL/L. THE SAMPLE WAS MANUALLY DILUTED 1:10 AND THE RESULT WAS 1.2 MMOL/L. THE CUSTOMER DECLINED TO PROVIDE INFORMATION ON WHETHER ANY OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DECLINED TO PROVIDE INFORMATION ON WHETHER THERE WERE ANY ADVERSE AFFECTS TO THE PATIENT. THE LITHIUM REAGENT LOT NUMBER WAS 660376 AND THE EXPIRATION DATE WAS 01/31/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64533 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1