BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3222389 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04217
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS ON THEIR C501 ANALYZER FOR 5 PATIENTS. THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLES BECAUSE THE PHYSICIAN QUESTIONED THE LOW RESULTS. THE SAMPLES WERE REPEATED ON (B)(6) 2013. PATIENT ONE HAD AN INITIAL SODIUM RESULT OF 129 MMOL/L. THE REPEAT RESULT WAS 137 MMOL/L. PATIENT TWO, A (B)(6) MALE, HAD AN INITIAL SODIUM RESULT OF 116 MMOL/L. THE REPEAT RESULT WAS 122 MMOL/L. PATIENT THREE, A (B)(6) MALE, HAD AN INITIAL SODIUM RESULT OF 134 MMOL/L. THE REPEAT RESULT WAS 143 MMOL/L. PATIENT FOUR, A (B)(6) OLD FEMALE, HAD AN INITIAL SODIUM RESULT OF 129 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. PATIENT FIVE, AN (B)(6) OLD MALE, HAD AN INITIAL SODIUM RESULT OF 118 MMOL/L. THE REPEAT RESULT WAS 128 MMOL/L. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE SODIUM ELECTRODE LOT NUMBER WAS R95. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. IT WAS NOTED AFTER THE EVENT THAT THE CALIBRATION WAS HIGH. IT WAS NOTED THAT THE RECOMMENDED DAILY QUALITY CONTROLS WERE ONLY RUN IN THE MIDDLE OF THE EVENT AND THE RESULTS WERE LOW. CALIBRATION AND QUALITY CONTROLS WERE PERFORMED BEFORE REPEATING THE SAMPLES AND WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323358 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 003 YR